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 auditsformanufacturing 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, processesand 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 projectsandongoing work activities within the department typically involving cross-functional representatives.

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

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

• Develop and maintain policies, standards, proceduresand 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

• Applicant must have a High School Diploma (or Equivalent) with 10+ years of relevant experience;

• OR an Associate's degree with eight years of experience;

• OR a Bachelor’s degree with at least 5+ years of experience;

• OR a Master’s degree with more than three years of experience;

• OR a Ph.D. with 0+ years of experience.

• People Management experience.

• Thorough knowledge ofcGLP/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

• 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.

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to stand for an hour or two during periods of time throughout the day.
• Must be able to lift 40 lbs.
• Must be able to sit in front of a computer for long periods of time, as needed.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• No travel required.
• This role is primarily day shift, Monday – Friday, with 24/7 support of manufacturing as operational issues arise.
• Additional hours are worked as needed to keep up with deliverables.

Other Job Details

Work Location Assignment:On Premise

Relocation Assistance Available: NO

Last date to apply: 11/10/2024

The annual base salary for this position ranges from $99,900.00 to $166,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control

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