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.
  Quality Assurance and Control

• 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