Cpl in partnership with our client Pfizer are currently recruiting for an 11-month
Contractor Quality Lead (CQL)
Department: External Supply Operations Quality (ESOQ)
Position reports to: ESOQ Quality Lead (Team Leader)
Actively contributes to ensure that Pfizer network of External suppliers/CMO’s/partners are supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines/applicable GMP regulations.
- Managing all aspects related to product quality or compliance for a portfolio of external contract manufacturers (CMO) and suppliers that supply materials/product(s) to Pfizer according to established procedures.
- Assess the quality of external supplier’s products, processes and related documents while ensuring the product specifications are met and quality systems are maintained.
- Supporting internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio or contractors – (Corporate audits or Regulatory Inspections) as applicable.
- Supporting internal and external partners with Compliance Assessments to ensure current GMP adherence.
- Supporting onboarding activities of new CMO’s or product launches within the portfolio as applicable.
- Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.
- Influence quality decision-making in line with industry and Pfizer requirements.
- Provide Quality Leadership within the cross-functional virtual site operating teams (VSOT).
- Partner with colleagues to develop and negotiate quality agreements.
- On time disposition of Product.
- May identify, develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.
- Ensuring the adequate tracking and documentation of all required quality relation actions in the relevant system(s) and ensuring that all required escalation processes are followed.
- Leading and supporting investigations, market complaints. Risk assessments in support of products within your portfolio. Connect with SME’s where needed.
- Working independently, receiving instructions primarily on unusual or complex problems.
- Building, maintaining, and developing relationships with key stakeholders, both internal and external to Pfizer.
- Supporting ESOQ leadership on other tasks as required.
- Minimum Bachelor of Science Degree, Pharmacy Engineering, or related technical discipline
- Minimum of 8 years’ experience in Quality Assurance.
- Minimum of 5 years’ experience in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions, and/or 10 years’ experience in the pharmaceutical or medical device industry.
- Advanced computer skills for MS Office suite and good knowledge of enterprise systems such as SAP, QTS, Vault, PDM, Documentum platforms.
- Proficient in English (written and spoken).
- Strong technical writing skills.
- Strong verbal, written communication, and presentation skills.
- Demonstrated personal leadership to work in virtual teams and in cross-functional projects/activities.
- Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices.
- Demonstrated technical know how.
- Proven leadership/facilitation skills and being able to involve several levels of an organisation to successfully meet the objectives.
- Master’s degree and +10 years related pharmaceutical experience.
- Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role.
- Experience with sterile large volume injectables (flexible bags).
- Experience with external suppliers/contractors
- Experience in managing investigations (DMAIC, 6sigma, etc.)
- Candidate demonstrates the ability to influence peers.
- French language – verbal and written.
- Up to 20% national travel.