Manager, Quality Assurance (2nd Shift)

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 designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and 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 who rely on our products.
What You Will Achieve
In this role, you will:
You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
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 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.
How You Will Achieve It
- Manage and provide guidance and coaching to Quality Operations team and provide direction or approval of activities and decisions.
- Manage multiple projects and ongoing work activities within the division typically involving cross-functional representatives.
- Manage the specific Inspection preparation plan for key Good Manufacturing Practices {also cGMP} elements etc.
- Take independent actions and decisions and motivate key stakeholders to deliver quality outcomes for business requirements.
- Provide Quality Assurance expertise to colleagues On and off the Manufacturing floor as required.
- Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer's standard processes and quality systems.
- Assist in key site quality behavior establishment, set clear company policies and behavior expectation for team member.
- Manage and conduct regular Production areas walkthroughs (Area product clarences, GMP and compliance walkthroughs)
- Assist Quality Operations Deviations and Product Floor Support for all planned and unplanned manufacturing deviations.
- Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
- Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
- Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
- Review and approval of validation documents Process, cleaning & method validation.
- Manage and conduct On floor QA review of executed batch records and Logbooks to assure compliance with regulatory standards and regulatory filing.
- Quality Assurance approval of SOPs, Campaigns start up Form and QA validation protocols and reports.
- Prepare departmental budgets and control the departmental cost within the budgets.
- Interface with Regulatory Agencies in audits.
Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of
  experience;
• OR a master's degree with at least 2 years of experience;
• OR a PhD with 0+ years of experience;
• OR as associate's degree with 8 years of experience;
• OR a high school diploma (or equivalent) and 10 years of
  relevant experience
• Working knowledge of current Good Manufacturing Practices {cGMP} for a pharmaceutical industry
• Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced
• Strong collaboration, relationship management, and interpersonal skills
• Stong critical thinking skills and ability to make decisions and know when to escalate issues as they arise
• Strong people management experience
• Excellent written and oral communication skills
• Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent

Bonus Points If You Have (Preferred Requirements)

• Master's degree with a solid understanding of device and combination product industry regulations
• Strong analytical and problem-solving skills
• Ability to work independently and make decisions
• Excellent organizational and time management skills
• Experience in interfacing with regulatory agencies during audits
• Ability to drive continuous improvement initiatives

PHYSICAL/MENTAL REQUIREMENTS

• Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.
• Ability to stand for 1 hour at a time, walk long distances and bend to obtain items from lower shelving/cabinets.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to work Rotating 2nd Shift Schedule. 2pm to 2am. 3/2/2 schedule.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $102,900.00 to $171,500.00. 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.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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