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 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