Quality Assurance Lead - GMP Biologics

SLS Services Limited; Cambridge; On-site; GBP 60,000 - 80,000; Full time

Job summary

A pioneering company in Cell & Gene Therapy is seeking a QA Lead to oversee the Quality Management System. The ideal candidate will have strong QA experience in GMP settings, especially in biologics or vaccines. This role offers competitive salary and benefits, as well as the opportunity to develop leadership skills while contributing to innovative therapies.

Benefits

Competitive salary

Bonus

Pension

Qualifications

• Experience in biologics, vaccines, or cell & gene therapies required.
• Previous managerial experience is desirable.
• Familiarity with regulatory authorities and GMP standards.

Responsibilities

• Lead the QA Operations team in managing the QMS.
• Support new product introduction and documentation review.
• Participate in audits and provide subject matter expertise.

Skills

Strong QA experience with GMP quality systems

Problem-solving skills

Strong interpersonal and communication skills

Education

BSc, MSc, or similar in a life science discipline

Job description

Are you an experienced Quality Assurance professional looking to step up into management? Do you have a strong knowledge of GMP operations and the manufacture of biologics, vaccines, or advanced therapies? Are you ready for an exciting new challenge?

A pioneering company in the Cell & Gene Therapy sector is seeking a QA Lead to join their Quality Department. Reporting to the Head of Quality Assurance, the QA Lead will ensure that the facility meets the standards and expectations of key stakeholders, regulatory authorities, and collaborators.

This position provides a unique opportunity to develop your leadership skills and contribute to obtaining a manufacturing license for a cutting-edge sterile vaccine manufacturing facility. A competitive salary and benefits package, including a bonus and pension, are on offer.

Key Responsibilities

• Provide leadership to the QA Operations team, ensuring effective management of the Quality Management System (QMS) and supporting ongoing design, commissioning, and validation activities.
• Offer support for new product introduction (NPI), batch-related documentation review, and investigation of failures, ensuring appropriate actions are identified, reviewed, and implemented.
• Lead efforts to establish governance processes ensuring the manufacture of products conforming to GMP regulations and expectations of customers or collaborators.
• Actively participate in audits and inspections, interacting directly with inspectors.
• Provide subject matter expertise for QA across the facility and facilitate GMP issue escalation through the QMS.
• Support the execution of the GMP internal audit program, identifying, reviewing, and implementing corrective actions.
• Assist with recruitment and development of a high-performing quality team and conduct performance reviews for team members.

Skills & Experience

• Strong QA experience working with GMP quality systems in a Phase III or commercial pharmaceutical facility, particularly in biologics, vaccines, or cell & gene therapies.
• BSc, MSc, or similar in a life science discipline.
• Experience working in smaller or start-up organizations, with a pragmatic attitude and strong problem-solving skills.
• Significant experience in biologics, particularly cellular and/or gene therapies.
• Previous managerial experience is desirable.
• Experience building and establishing GMP quality systems in a Phase III or commercial manufacturing facility.
• Familiarity with regulatory authorities and the global standards for GMP manufacture, including EU, MHRA, FDA, and ISO 9001.
• Strong interpersonal, communication (oral and written), and influencing skills, with the ability to engage constructively with colleagues at all levels across departments.

This role offers a unique opportunity to shape and influence the quality operations of a growing organization at the forefront of innovative therapies.