Hybrid Quality Assurance Manager bei Pfizer

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.

What You Will Achieve

In this role, you will:

• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work
• Make decisions to resolve complex problems, develop new options guided by policies, and operate independently in ambiguous situations
• Support the development of quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs
• Ensure reference standard testing is conducted in a manner consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance.
• Review/approve various types of laboratory documentation. These documents would include (but are not limited to) laboratory investigation reports, deviation reports, change control documentation, certificate of results, laboratory instrument qualification/calibration, laboratory procedures, memorandums and quality alerts according to procedure requirements.
• Create, track and approve corrective/preventative action items to help ensure they are completed with the agreed timeframes.
• Provide QA approval of Reference Standard Materials in the Reference Standard Database.
• Perform internal audits or host external audits as needed and provide timely feedback during the audit process. Assure adequate follow-up and resolution of external or internal audit findings.
• Provide support with the training and document management systems within SLS.
• Leading and participating on limited duration teams to achieve specific objectives.
• Managing assigned tasks/projects within agreed upon timeframes.

Here Is What You Need (Minimum Requirements)

• Bachelor's Degree in Chemistry, Biology or Other Health Science
• 15+ years' experience working in the Pharmaceutical Industry or other GMP setting with an emphasis in Quality Assurance.
• Thorough knowledge and understanding of the technical and commercial aspects of a Corporate Reference Standard Program, Current Good Manufacturing Practices {part of GxP}, validation principles, and applicable regulations
• Demonstrated record of successful interaction with global regulatory and other internal and external auditing groups
• Experience in conducting GMP system audits.
• Strong understanding of QA requirements and is aware of industry trends
• Experience in preparing and negotiating Quality Agreements with contract sites
• Good understanding of the principles and application of quality risk management
• Ability to manage multiple projects simultaneously typically involving cross functional teams.
• Excellent verbal and written communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups

Bonus Points If You Have (Preferred Requirements)

• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Knowledge or exposure to data science
• Strong leadership and team management skills
• Ability to work under pressure and meet tight deadlines
• Ability to influence and negotiate with stakeholders
• Advanced computer skills in MS office applications and good knowledge of enterprise systems, such as PDM, EQMS, Documentum platforms

  
 Non-Standard Working schedule, Tavel or Environment Requirements:

Some after hour/weekend work maybe required

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.