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