Job Description

Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will have the all-important role of conducting audits for manufacturing plants and distribution centers, prior to corporate level audits. You will be relied on to make sure that they comply with the policies, procedures and practices laid down by domestic and international and applicable ISO standards. Your attention to detail will help in reporting inefficient procedures, policy exceptions and discrepancies. You will suggest the needed corrective actions and help the with manufacturing management to establish the necessary practices and procedures.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Manage multiple projects and ongoing work activities within the department typically involving cross-functional representatives.

Manage a team of quality professionals/supervisors/leads to achieve quality, compliance and business objectives in the business group.

Analyze, develop and improve quality systems and associated business processes to achieve compliance with global regulatory requirements.

Develop and maintain policies, standards, procedures and guidelines encompassing all quality systems and, facilitate deployment.

Provide leadership in quality programs and initiatives; make recommendations to continuously improve systems.

Conduct internal compliance audits, manage timelines and schedules, generate audit reports, review audit responses and conduct follow-up to track resolution.

Support investigation activities utilizing root-cause and problem-solving methodologies as well as support CAPA development and implementation.

Develop and maintain department and site metrics for monitoring critical process and Quality attributes.

Review and approve appropriate technical documentation in support of cross-functional and cross-departmental projects.

Provide guidance and coaching to QA colleagues and provides direction/approval of activities and decisions.

Cultivate and reinforce appropriate group values, norms and behaviors.

Provide oversight to individuals and team on personal development, performance and quality related issues.

Qualifications Must-Have

Bachelor's Degree and 5+ years' of experience.

People Management experience.

Thorough knowledge of cGLP/cGMP and regulations.

Effective communication skills, both written and verbal.

Strong interpersonal skills and the ability to handle multiple projects.

Strong analytical and problem solving abilities.

Nice-to-Have

Master's degree and relevant pharmaceutical experience.

Certified Manager of Quality Organization Excellence, or similar certification.

Certified Lean Six Sigma Black Belt, or similar certification.

Project management experience.

Experience in at least several of the following: GMP, Regulatory (worldwide), deviation investigation, drug product lot release, aseptic manufacturing processes, product and process validation, laboratory testing and investigations and batch record review. Work Location Assignment: Flexible

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

4860842