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Senior Quality Assurance Leader
2 months ago
AssureBio is seeking a Senior Quality Assurance Leader to become an integral part of our diverse team, dedicated to the production of groundbreaking therapeutic solutions that have the potential to transform lives.
This role presents an exceptional opportunity for a Quality Assurance professional eager to engage in the development of pioneering medicinal products and to participate in the expansion of GMP manufacturing to address the increasing demand for critical research.
Primary Responsibilities:
- Product Certification: Validate Investigational Medicinal Products (IMPs) and Advanced Therapy Medicinal Products (ATMPs) while ensuring adherence to current and evolving regulatory standards.
- Import Compliance: Execute QP declarations for products imported from various regions, including India and the USA.
- Activity Oversight: Supervise QP functions such as partial batch production, clinical trial labeling, and final product certification.
- Quality Management: Collaborate with the Quality Head to uphold a robust Quality Management System in line with EudraLex Volume IV.
- Management Communication: Relay quality and regulatory updates to the Senior Management team.
- Training and Compliance Audits: Conduct training sessions, self-assessments, external audits, risk evaluations, change management, CAPAs, and investigations related to deviations, out-of-specifications, complaints, and product recalls.
- Contract Oversight: Manage activities performed by contract QPs and ensure the efficacy of the Quality Management System.
- GMP Knowledge: Offer GMP insights for significant capital projects concerning facilities and equipment.
- Regulatory Guidance: Provide advice to internal and external personnel on legislation and guidelines for innovative manufacturing processes and quality control testing strategies, including leading discussions with regulatory bodies.
Essential Qualifications and Experience:
- Degree in Chemistry, Biology, or Pharmacy.
- Membership or higher standing in the Royal Pharmaceutical Society, the Royal Society of Biology, or the Royal Society of Chemistry.
- Experience in the production of biological and sterile medicinal products.
- Proficiency in managing all facets of Quality Assurance within a GMP-regulated environment.
- In-depth knowledge of EU GMP regulations (EudraLex Volume 4) and the ability to interpret these for early-phase IMPs and ATMPs.
- Experience as a Pharmaceutical Auditor.
- Leadership or supervisory experience with demonstrated management skills.
- Extensive scientific and technical knowledge in a GxP setting, along with significant experience in a manufacturing or Quality role.
Desirable Experience:
- Comprehensive experience in biopharmaceutical, ATMP, or vaccine production.
- Broad understanding of contemporary and innovative technical and scientific processes, including various bioprocessing methodologies and analytical techniques.
- Experience in hosting regulatory inspections and external audits.
- Experience in importing IMPs and ATMPs from the EU and other regions.
Benefits:
- Competitive Salary
- Excellent contributory pension scheme
- 38 days annual leave
- Comprehensive childcare services
- Family leave schemes
- Cycle loan scheme
- Discounted bus travel and Season Ticket travel loans
- Membership to a variety of social and sports clubs
- A welcoming and diverse community
**Join us in contributing to the advancement of innovative medicinal products with the potential for transformative impact.**
