Senior Quality Manager - Cell Therapy

Location: Oxfordshire
Contract Type: Permanent

• Oversee the Quality Management System (QMS) for a leading pharmaceutical company developing innovative T cell-priming product candidates
• Collaborate with senior management to ensure compliance with company policies and Standard Operating Procedures (SOPs)
• Maintain the Pharmaceutical Quality System in compliance with Good Clinical Practice and Clinical Trials Regulations
• Competitive salary package including 20% bonus and health insurance
• Hybrid work arrangement offering flexibility and work-life balance

Our client, a pioneering pharmaceutical company, is seeking a Senior Quality Manager to oversee and maintain the Pharmaceutical Quality Systems at their development, manufacturing, and testing site in Oxfordshire. This is an exciting opportunity to play a crucial role in ensuring the quality and compliance of their innovative T cell-priming product candidates for infectious diseases and immunotherapy indications.

Position Overview

As the Senior Quality Manager, you will be responsible for providing strategic direction and oversight of the Quality Management System (QMS) at our client's state-of-the-art facility. You will work closely with senior management to ensure that quality planning aligns with corporate objectives and current pharmaceutical regulations, while maintaining regular surveillance of forthcoming legislation that may impact the organization.

Responsibilities

• Provide direction supporting Quality Assurance to ensure Quality planning is aligned with corporate strategic objectives and current pharmaceutical regulation
• Oversee the Quality Management System (QMS)
• Analyze, evaluate, and present quality-related data concerning business programs, capabilities, problems, and trends to the senior management team
• Collaborate with senior management in promoting compliance with company policies and Standard Operating Procedures (SOPs)
• Oversee the manufacture, testing, storage, and distribution of pharmaceutical products in compliance with The Human Medicines Regulations (SI 2015/1916) and guidance governing pharmaceuticals
• Maintain the Pharmaceutical Quality System to comply with Good Clinical Practice and Clinical Trials Regulations
• Oversee and, where required, carry out supplier qualification audits and supplier approvals, assisting the Quality Assurance Team in maintaining the required level of assurance in the supply chain(s)
• Oversee and maintain a recall and complaints system, ensuring full and prompt co-operation with national and international regulatory agencies in the event of product recalls, complaints, and/or product defects
• Maintain the deviation and error reporting system and the required follow-up actions including impact analysis, root cause analysis, and effectivity checks

Requirements

• Bachelor's degree in a life science
• Minimum of two years' professional experience in pharmaceutical quality management
• Demonstrated technical knowledge in areas of pharmaceutical manufacturing, quality control, release testing, and legislation regarding the manufacture, testing, storage, and distribution of medicinal products
• Full working knowledge of The Human Medicines Regulations (SI 2015/1916) and Eudralex Volume IV parts I and II
• Understanding of the principles of quality management and conversant with ICH Quality Guidelines Q8, Q9, and Q10
• Knowledge and implementation experience in relevant legislation and guidance, including The Human Medicines Regulations (SI 2015/1916), Directive 2001/83/EC, EU GMP Directive 2003/94/EC, EU guidelines on GDP 2013/C 343/EC, UK regulations on Good Distribution Practice, and The European Clinical Trials Regulations 536/2014
• Strong interpersonal skills and the ability to effectively communicate within a team environment
• Effective investigation skills
• Creative and accommodating thinking in the context of regulatory compliance
• Willingness to accommodate a company personal development plan

Company Overview

Our client is a trailblazing pharmaceutical company dedicated to positively impacting global human health through the development of innovative T cell-priming product candidates for some of the world's most immediate health threats. Utilizing their core proprietary technologies, they are developing an extensive range of synthetic vaccine and immunotherapy candidates for infectious diseases and immunotherapy indications. With a strong focus on innovation and a commitment to making a difference, our client offers an exciting and rewarding work environment for those passionate about advancing human health.

Benefits

• Competitive salary package
• 20% bonus
• Health insurance
• 28 days annual leave
• Hybrid work arrangement

Working alongside a talented and dedicated team, you'll be immersed in a culture driven by the shared mission of positively impacting global human health. Our client fosters a collaborative and supportive environment that values innovation, excellence, and continuous learning.

Job Title: Microbiologist

About the Company:

Our client is a leading global pharmaceutical company committed to innovation, quality, and compliance in healthcare. With a strong presence in the industry, they focus on delivering life-changing medicines while ensuring the highest standards in manufacturing and safety.

Role Overview:

We are seeking a Microbiologist to join our on-site team at a state-of-the-art pharmaceutical manufacturing facility. The successful candidate will be responsible for ensuring microbiological compliance in production processes, conducting laboratory testing, and supporting quality assurance activities. This role plays a critical part in maintaining the safety and efficacy of pharmaceutical products.

Key Responsibilities:

• Conduct microbiological testing on raw materials, in-process samples, and finished products.

• Perform environmental monitoring and water testing to ensure compliance with regulatory standards.

• Investigate and report microbiological deviations, trends, and contamination events.

• Develop and validate microbiological methods in alignment with industry standards.

• Support sterility assurance programs and contamination control strategies.

• Maintain accurate documentation and laboratory records in compliance with GMP, FDA, EMA, and MHRA regulations.

• Collaborate with cross-functional teams, including Quality Assurance and Manufacturing, to troubleshoot microbiological issues.

• Participate in internal and external audits to demonstrate compliance with microbiological standards.

• Provide technical expertise and training on microbiological best practices to site personnel.

Requirements:

• Bachelor’s or Master’s degree in Microbiology, Biology, or a related field.

• Minimum 3-5 years of experience in a microbiology role within a pharmaceutical, biotech, or healthcare industry.

• Strong knowledge of GMP regulations, aseptic processing, and microbiological quality control.

• Experience with environmental monitoring, sterility testing, endotoxin testing, and microbial identification.

• Ability to analyze data, identify trends, and provide recommendations for process improvements.

• Strong communication and teamwork skills to work effectively in a regulated environment.

• Proficiency in laboratory techniques and use of microbiology laboratory equipment.

Job Title: Quality Manager / Responsible Person (RP)
Location: Dublin
Reports To: Director of Quality

About the Company:

Our client is a global leader in clinical trials, dedicated to delivering high-quality solutions that meet regulatory and customer requirements. With operations worldwide, the company is committed to innovation, compliance, and excellence in the healthcare industry.

Role Overview:

The Quality Manager / Responsible Person (RP) will oversee the Quality Management System (QMS) to ensure compliance with regulatory requirements and industry standards for clinical trials, packaging, and labelling. Reporting directly to the Director of Quality, the role will involve leading the Quality team, managing daily quality operations, and ensuring Good Distribution Practice (GDP) compliance. The successful candidate will play a key role in maintaining the company’s high standards of quality, safety, and regulatory adherence.

Key Responsibilities:

Act as the Responsible Person (RP), ensuring compliance with Good Distribution Practice (GDP) and other regulatory requirements.

Lead, mentor, and develop the Quality team, overseeing their performance and professional growth.

Manage and maintain the Quality Management System (QMS), ensuring compliance with EU and global regulatory standards.

Oversee the packaging and labelling processes to ensure quality assurance and compliance.

Ensure the company meets all regulatory licensing and certification requirements.

Conduct internal audits, supplier audits, and manage external regulatory inspections.

Develop and implement quality policies, procedures, and continuous improvement initiatives.

Handle deviations, CAPAs, change controls, and other quality-related activities.

Provide training and guidance to staff on GDP, regulatory updates, and quality best practices.

Ensure proper complaint handling, recall procedures, and product release processes.

Collaborate with cross-functional teams to drive operational excellence and compliance.

Requirements:

Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Quality Management, or a related field.

Minimum 5-7 years of experience in a quality management role within clinical trials, pharmaceuticals, packaging, or labelling.

Proven experience as a Responsible Person (RP) under EU GDP requirements.

Strong knowledge of GDP, GMP, GCP, and regulatory requirements for clinical trial supply chain operations.

Experience leading and developing a high-performing team.

Excellent problem-solving, communication, and leadership skills.

Ability to manage multiple priorities in a fast-paced global environment.

Strong attention to detail and a proactive approach to quality management.

What We Offer:

Competitive salary and benefits package.

Hybrid working model (Dublin-based).

Career growth opportunities within a global organization.

A collaborative and innovative work environment.

Job Description - Qualified Person

CHR Life Sciences are pleased to be working in partnership with a pharmaceutical company based in the Midlands, who are actively seeking a Qualified Person to join their Site Leadership Team. As the Qualified Person, you will be tasked with batch release activities. You will also work with the wider Quality Assurance team to implement Quality improvements and help drive a Quality first culture.

Responsibilities include:

Undertake the duties of a Qualified Person as defined in SI 2012-1916 and Directive 2001/83/EC

Working closely with the site leadership to help advise on Quality issues and liaise with regulatory agencies.

As the Qualified Person, you will act as a point of contact for customers, giving exposure to the Quality standards.

You will help facilitate site wide GMP compliance. This will include managing and developing Quality Systems, including CAPA, OOS, Deviations, Change Controls and Root Cause Analyses.

The Successful candidate will:

Be certified as a Qualified Person, as per Directive 2001/83/EC.

Thorough knowledge of the legal requirements, rules and guidance covering the manufacture of pharmaceutical products.

Experience in pharmaceutical manufacturing of solid dosage forms.

QP | Qualified Person | Quality Assurance | QA | CAPA | QMS | Quality Systems | Audit | Documentation | Batch | SOP | Batch | Release

GCP Quality Manager - Leading Clinical Trials Innovator

Location: London, UK
Contract Type: Permanent
Salary: 55000

• Join a dynamic, mission-driven team dedicated to transforming clinical trial infrastructure
• Contribute to the development and implementation of robust GCP quality assurance processes
• Enjoy a supportive culture with unlimited holidays, flexible working, and personal development opportunities
• Benefit from competitive salary, generous stock options, and UK visa sponsorship for eligible candidates

Our client, a leading clinical trials innovator, is seeking a proactive and passionate GCP Quality Manager to join their growing team in London. This is an exciting opportunity to play a key role in ensuring the company's clinical trials consistently meet the highest regulatory standards.

Position Overview

As the GCP Quality Manager, you will be instrumental in developing and implementing quality assurance processes and procedures that are fully compliant with GCP and relevant regulations. Your expertise will help ensure that the company's clinical trials are conducted to the highest standards, ultimately contributing to the advancement of innovative healthcare treatments.

Responsibilities

• Support the development and implementation of GCP-compliant quality assurance processes and procedures
• Stay updated on national and international legislation, guidelines, and customer practices, providing consolidated information to the Quality & Clinical Operation Team
• Ensure the company's delivered studies consistently meet all regulatory requirements
• Maintain accurate and up-to-date documentation related to GCP and quality management processes
• Review study documents within the Clinical Operations Team to ensure compliance with current clinical trial regulations
• Support internal and external audits, preparing staff and trial materials for inspections by Sponsors and regulatory bodies
• Identify and assess risks associated with GCP, implementing risk mitigation strategies in collaboration with cross-functional teams

Requirements

• 3-5 years experience in GCP Quality roles
• Expertise in ICH GCP and multiple regional areas (MHRA and FDA experience beneficial)
• Demonstrated experience in Sponsor and regulatory GCP audits
• High agency and a proactive attitude
• Deep passion and curiosity for transforming healthcare operations and advancing new health treatments
• Desire to contribute to the dynamic environment of a high-growth, mission-driven, venture-capital-funded startup

Company Overview

Our client is a young and ambitious company founded in March 2021, dedicated to revolutionising the clinical trial landscape. With a mission to help innovative companies run faster, more reliable, and patient-friendly clinical trials, they have already made significant strides, successfully facilitating over 80 clinical trials involving thousands of patients. Their commitment to excellence has earned them an impressive customer NPS of 100 and recently secured $18 million in Series A funding to fuel their growth.

Benefits

• Competitive salary and generous stock options
• Unlimited holidays, with encouragement to take at least 28 days off each year
• Flexible office arrangement, with a 3-4 day per week in-office commitment initially
• Regular team events and opportunities for personal development through courses
• Provision of a new laptop and financial support for setting up a home office
• UK visa sponsorship for eligible candidates not already authorised to work in the UK

You'll be part of a dynamic, mission-driven team that values proactivity, personal development, and a deep passion for transforming healthcare. The company fosters a supportive and engaging work environment, offering regular team events and opportunities for growth.

• Join a leading generics company driving change and continuous improvement

• Support the implementation of GMP/GDP documentation and enhance the QMS

• Utilise your expertise in quality systems and pharmaceutical manufacturing

• Contribute to the resolution and communication of non-conformances

Our client, a leading generics company, is seeking a skilled Quality Assurance Specialist to join their team in the South East. This is an excellent opportunity for an experienced professional to contribute to the company's commitment to quality and continuous improvement.

Position Overview

The Quality Assurance Specialist will play a crucial role in supporting the company's quality management efforts, ensuring compliance with GMP/GDP regulations, and driving enhancements to the Quality Management System (QMS). This position offers the chance to make a significant impact within a family-oriented and change-driven organisation.

Responsibilities

• Perform gap analyses against quality management systems

• Implement GMP/GDP documentation and enhance the QMS

• Review batch production records against marketing authorisation specifications

• Support reviews of key SOPs and amend systems

• Undertake and develop risk assessments as needed

• Review investigations and root cause analyses of discrepancies

• Generate SOPs and other quality documentation

• Provide training and coaching to team members

• Generate metrics and utilise Microsoft Excel proficiently

Requirements

• Experience in Quality Assurance roles in pharmaceutical companies

• Hands-on experience in quality systems on pharmaceutical manufacturing sites

• Technical knowledge of pharmaceutical Quality Assurance and GxP

• Knowledge of continuous improvement in quality systems

• Ability to perform gap analyses and make value-adding suggestions

• Experience with electronic quality management systems (e.g., Q-Pulse)

• Familiarity with reviewing batch production records

• Strong organisational and prioritisation skills

• Self-starter with the ability to interpret data and present outcomes

• Excellent communication skills and experience in training and coaching

• Proficiency in Microsoft Excel and ability to generate metrics

Senior Recruitment Consultant

Location: City of London
Contract Type: Permanent

• Join a company founded on the pillars of Commitment, Honesty and Respect

• Collaborate with innovative life sciences companies to shape the industry's future

• Enjoy a competitive compensation package with commissions and bonuses

• Benefit from hybrid working arrangements and life events support

CHR Life Sciences is seeking a driven Senior Recruitment Consultant to join the team in the City of London. As a trusted partner for professionals and innovative companies, CHR Life Sciences plays a vital role in ensuring the future success of the life sciences industry.

Position Overview

The Senior Recruitment Consultant will be responsible for sourcing, interviewing, and managing compliance for candidates in complex niche roles. This position is crucial in meeting the staffing needs of our clients and contributing to the growth and success of the company.

Responsibilities

• Utilise various sourcing methods to attract qualified candidates for complex roles

• Conduct comprehensive interviews to assess candidates' skills, qualifications, and suitability

• Ensure candidates meet all regulatory and compliance requirements

• Collaborate with clients to understand their staffing needs and provide regular updates

• Stay updated on industry trends and identify opportunities for process improvement

• Develop and maintain strong relationships with key stakeholders in the life sciences sector

• Identify and pursue new business opportunities to expand the company's client base

• Attend industry events and networking functions to establish connections and promote the company's services

Requirements

• Previous recruitment experience

• Experience managing your own desk with consistent billings

• Strong interpersonal and communication skills

• Ability to build and maintain client relationships

• Knowledge of compliance requirements in the life sciences industry (Desirable) 

Company Overview

CHR Life Sciences is a respected name in the life sciences recruitment industry, known for their commitment to delivering exceptional service while upholding compliance at all stages. With a focus on honesty and respect, CHR Life Sciences builds successful partnerships with professionals and innovative companies. The company's passion for the industry and desire to see their collaborators succeed sets them apart in the market.

Benefits

• Competitive compensation package with commissions and bonuses

• Hybrid working arrangements

• Life events support

• Opportunities for professional development and career growth

At CHR Life Sciences, you'll be part of a team that values commitment, honesty, and respect. You'll have the opportunity to collaborate with innovative companies and contribute to the future of the life sciences industry.