Senior Director Chemistry Quality Assurance
Apply
Locations: GBR - London (Hammersmith Hospital)
Time Type: Full time
Posted on: Posted 30+ Days Ago
Job Requisition ID: JR103526
What can we offer you?
Apart from job satisfaction, we can offer you:
YOURSELF
* 25 days’ holiday (with the option to buy more)
HEALTH
* Private Healthcare
* Optional dental insurance, health assessments and health cash plans
* Cycle to Work scheme
WEALTH
* Company Pension Scheme, matching contributions up to 5% of salary
* Life assurance
* Annual staff bonus scheme
* Season ticket loans
Major Responsibilities:
* 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.
Qualifications:
* Bachelor’s degree; with a 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.
Unique Department Requirements:
* Works in an environment with radiopharmaceuticals.
What We Offer:
* Competitive salary.
* Full Benefits.
* 401k with generous matching.
* Flexible vacation policy.
#J-18808-Ljbffr