Senior Director Chemistry Quality Assurance

What can we offer you?

Apart from job satisfaction, we can offer you:

YOURSELF

• 25 days' holiday (with the option to buy more)

• Private Healthcare
• Optional dental insurance, health assessments and health cash plans
• Cycle to Work scheme

• Company Pension Scheme, matching contributions up to 5% of salary
• Life assurance
• Annual staff bonus scheme
• Season ticket loans

• Ownership of Quality systems program for GMP work conducted at Invicro sites globally:
• Oversight of batch disposition and release activities and processes at Invicro sites
• Coordinating with Quality Systems team in managing responsibilities regarding:
• GMP Document Management (e.g. master batch records, testing standard, component specification sheets).
• Employee GMP Training and Qualification (Annual GMP refresher training, aseptic training, media fill qualification).
• Chemistry Equipment Compliance.
• Non-conformance and CAPA Program as related to Chemistry department.
• Oversight of GMP Sponsor audits and requests for information (RFI's)
• Oversight of GMP Internal Audit schedules
• Development, maintenance and oversight of site-level GMP control strategies
• Assess and implement alignment of GMP activities across the global organisation
• Support vendor management
• Point of reference for GMP quality requirements for internal and external stakeholders
• Liaising with external stakeholders and establishing GMP quality agreements
• Coordinating with operational teams in managing GMP project/product timelines
• Support Regulatory Affairs in IND applications and CMC submissions
• Participate through leading or being a contributing member of Invicro's quality/regulatory councils
• Provide mentorship, supervision and professional development to direct reports.
• Provide guidance to peers in best practices to implement the quality goals, as defined by senior leadership.

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• Bachelor's degree; with minimum of 10+ years in a regulatory or QA environment.
• Working knowledge of ICH, MHRA, and FDA GMP requirements
• Experience hosting regulatory and/or sponsor audits and conducting audits (internal and/or vendors).
• Strong communication skills with internal and external stakeholders
• Organizational skills; highly motivated and detail oriented.
• Management and/or project leadership experience are required; experience working collaboratively cross-organizationally is essential.

• Works in an environment with radiopharmaceuticals

• Competitive salary
• Full Benefits
• 401k with generous matching
• Flexible vacation policy