Group Manager-Chemical Quality

Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
What You Will Achieve
In this role, you will:

• Lead people, technology, and financial resources within the department.
• Actively share knowledge and identify potential improvements in processes or products, taking risks to develop innovative ideas.
• Solve moderately complex problems within your expertise and assist with issues outside the department.
• Oversee operational activities to support the department's short-term goals and manage the performance of direct reports through goal setting, coaching, and ongoing assessment.
• Recognize the need for development in others, collaborate to create development plans, and foster teamwork and colleague development.
• Solicit input, explain complex concepts, and persuade others to adopt a point of view while effectively sharing your own perspective and rationale.
• Ensure alignment with all regulations and Pfizer Quality Standards, managing Direct reports.
• Guide lab analysts on continuous improvement tools such as standard work and visual management, and review and approve documentation associated with Good Manufacturing Practices (cGMP).
• Collaborate with site functional areas and customers to support site goals, objectives, and timelines, maintain alignment with industry best practices, represent the area in meetings and audits, and set up departmental metrics to achieve operational effectiveness.

Here Is What You Need (Minimum Requirements)

• B. Pharm/ M. Pharm / M.Sc. with at least 10 years of relevant pharmaceutical industry experience and strong background in Quality Control
• Planning and managing of regular analytical activities related to retention samples visual inspection as per defined schedule.
• Ensuring that all stability samples are pulled as per schedule and completion of the testing within time period.
• Approval of stability protocols and compilation reports.
• Ensuring that on time submission of annual reports.
• Handling of internal and external audits.
• Support for on time closure of Incidents / CAPA / CCF related to section.
• Ensuring PRQ of stability chambers as per schedule.
• Ensuring Personnel safety in the Quality Control, Safe handling of materials.
• Providing impact assessment for cross functional Change controls.
• Approval of stability and retention samples request
• Approval of Standard operating procedures related to Stability management.
• Ensuring the sponsor site stability samples, temperature data during shipment and the conducting of stability studies at site.
• Extensive knowledge of Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories
• Proficiency in a wide range of analytical techniques
• Strong reasoning abilities, including analytical and problem-solving skills
• Significant people management experience
• B. Pharm/ M. Pharm / M.Sc. 10+ years with at least 10 years of relevant pharmaceutical industry experience and strong background in Quality Control
• Planning and managing of regular analytical activities related to retention samples visual inspection as per defined schedule.
• Ensuring that all stability samples are pulled as per schedule and completion of the testing within time period.
• Approval of stability protocols and compilation reports.
• Ensuring that on time submission of annual reports.
• Handling of internal and external audits.
• Support for on time closure of Incidents / CAPA / CCF related to section.
• Ensuring PRQ of stability chambers as per schedule.
• Ensuring Personnel safety in the Quality Control, Safe handling of materials.
• Providing impact assessment for cross functional Change controls.
• Approval of stability and retention samples request
• Approval of Standard operating procedures related to Stability management.
• Ensuring the sponsor site stability samples, temperature data during shipment and the conducting of stability studies at site.
• Extensive knowledge of Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories
• Proficiency in a wide range of analytical techniques
• Strong reasoning abilities, including analytical and problem-solving skills
• Significant people management experience and m anages the performance of direct reports through goal Attention to detail.

Bonus Points If You Have (Preferred Requirements)

• Master's degree
• Knowledge in the application of statistical tools, root cause analysis, and/or six sigma methodologies
• Expertise in Quality Control (QC) instruments
• Experience in setting requirements for the transfer of methodology from Research and Development (R&D)
• Ability to manage projects and ongoing work activities of moderate complexity
• Excellent verbal and written communication skills
• Ability to foster teamwork and colleague development

Work Location Assignment: On Premise
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
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