Mgr/TL Quality Operations

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 and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control (QC) instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from Research and Development (R&D).

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 dedication 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 of moderate complexity within the division typically involving cross-functional representatives.

• QO Technical Knowledge (understand GMP compliance, Kalamazoo product knowledge)

• Quality Systems Knowledge (understand related quality and compliance systems including deviations, change management, validation, documentation, etc.)

• Manage Colleagues (performance reviews, development discussions, build teams, foster colleague engagement, deliver results, manage through others, etc.)

• Operation Knowledge Preferred (Supply chain, DP or API equipment & processes to make product)

• Understand regulatory requirements and audit strategy

• Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

• Review and approve documentation associated with Good Manufacturing Practices {also cGMP}, method validation, investigation of change controls and technical reports.

• Collaborate with site functional areas and customers to support site goals, objectives and timelines.

• Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight and work with other management teams to ensure support for all testing activities in the routine testing area.

• Provide oversight of Microbiology product testing group responsible for routine testing of product or process samples for endotoxin, sterility, bioburden, etc.

• Oversee project management of all Data Integrity related activities with the relevant teams.

• Address and resolve any potential issues with regulatory impact.

• Develop and maintain alignment with current industry best practice related to cleanroom techniques and share with the respective teams.

• Represent area of responsibility at meetings and in audits.

• Provide information, discuss problem batches, manufacturing/technical issues, deviations and other events with potential impact on product quality and/or supply.

• Foster teamwork and colleague development, as well as change management, within the department and set up departmental metrics to achieve operation effectiveness.

Qualifications

Must-Have

• Bachelor's Degree in Chemistry, Biochemistry, Microbiology, or related science 

• 5+ years' experience

• Demonstrated experience in Quality Control

• Extensive knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques

• Reasoning ability including strong analytical and problem solving abilities

• Strong people management experience

• Strong verbal and written communication skills

• Demonstrated partnership with various organizations

• The successful candidate will have demonstrated strong scientific reasoning and problem solving, as well as excellent written and oral communication skills.  They will be able to engage colleagues globally, and will do so in a manner that recognizes the organizational and cultural differences that may exist between their partners around the world.  They will also have excellent negotiation skills, and will be able to frequently resolve issues with a focus on regulatory compliance.  They will have demonstrated skill in developing solutions, and will do so with a flexible approach to the development of options.

Nice-to-Have

• Master's degree

• Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

• Experience in quality control and/or quality assurance within the pharmaceutical industry

Physical/Mental Requirements

Office work requiring walking, standing, and sitting throughout a shift. Lifting of items less than 25 kg

There is no routine travel associated with this position.

Other Job Details

• Last Date to Apply: January 31, 2022
• Eligible for Relocation Package

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control

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