Contract Quality Lead

ROLE SUMMARY

Reports to ESOQ Team Leader (Site Quality Operations Lead)

Actively contributes as part of the External Supply Operations Quality T2 structure to ensure that Pfizers network of External suppliers / CMOs / partners are supported to deliver high quality products on time and in compliance with all established standards and agency guidelines.

ROLE RESPONSIBILITIES

• Managing all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply product(s) to Pfizer according to established procedures.
• Assess the quality of external suppliers 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 of contractors - (RQA or regulatory audits) as applicable
• Supporting onboarding activities of new CMOs 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.
• Have the ability to influence quality decision making in line with industry and Pfizer requirements
• 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 related actions in the relevant system(s) and ensuring that all required escalation processes are followed.
• Leading and supporting complex investigations / risk assessments in support of products within your portfolio
• Working independently and operating with minimal supervision interacting with high levels of management both at contract manufacturers and within Pfizer.
• Building maintaining and developing relationships with key stakeholders both internal and external to Pfizer.

BASIC QUALIFICATIONS

• Minimally Bachelor of Science Degree Engineering or related technical discipline
• Minimally 5 years experiences 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 MSOffice and enterprise systems such SAP QTS Vault Documentum platforms
• Proficient in English
• Strong technical writing skills
• Strong verbal written communication and presentation skills
• Demonstrated personal leadership to work in virtual teams and in cross functional projects/initiatives
• Is diplomatic clear & succinct in communication with internal and external stakeholders
• Demonstrated experience managing complex quality and compliance activities
• Demonstrated managerial/organizational skills
• Takes initiatives and is proactive persistent
• Good organizing and planning skills and a high sense of urgency
• Demonstrated ability to prioritize work to act and work independently and to report items as required to line manager
• 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 organization to successfully meet the objectives.

PREFERRED QUALIFICATIONS

• Masters degree and 10 years relevant pharmaceutical experience.
• Demonstrated experience in pharmaceutical manufacturing activities (API DP Biotech Oral Solid Dosage Aseptic) applicable to the role
• Experience with external suppliers/contractors
• Candidate demonstrates the ability to influence and collaborate with peers

Work Location Assignment:Hybrid

CLOSING DATE 10 OCTOBER 2025