Mgr/TL Vaccine Quality and PPS

ROLE SUMMARY

This posting is for a Manager/TL position in the Vaccine (Vx) Drug Product Quality Assurance team (1st shift) providing management support for the Pick, Pack, and Ship (PPS) team as well as backup management support for the QA Vaccine team. This position is also a working manager position, conducting real time quality impact support (floor support), investigation support, and other QA functions. This role is part of the greater DP QA team, whose responsibility is to ensure timely release of conforming Drug Product, upholding cGMPs as well as timely completion of  non-conformance investigations reports with effective corrective/preventative actions (CAPA).

Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions.  Cultivates and reinforces appropriate group values, norms, and behaviors.  Provides oversight to individuals and team on personal development, performance, and quality related issues.  Writes and delivers performance reviews and performs second level reviews as required.  Provides oversight of department, ensuring proper use of assets, budget, and personnel.  Communicates effectively with key customers and partners, both within the site and outside of it.

ROLE RESPONSIBILITIES

Primary responsibilities are management support of the Pick, Pack, and Ship team and investigation/floor support within the QA Vaccine team.

Management – This role manages the Pick, Pack, and Ship (PPS) QA team.

• Manages the PPS team – a team of Quality Assurance professionals (6-8) who are responsible for overseeing quality critical parameters and documentation associated with the PPS process.
• This position is responsible to maintain the structure to ensure that all quality commitments and timelines are tracked and met. 
• Assists senior leaders at the site in resource and budget preparations.
• Reviews and approved quality investigations, SOPs, OJTs, and other area specific documents.
• IMEx PCT Lead – responsible for managing this IMEx PCT, developing IMEx systems, escalating issues, and insuring metrics are met.
• Leads CI projects associated with PPS

Floor Support

• Independently provide real time quality impact assessments and decisions on vaccine manufacturing issues
• Acts as a quality representative for manufacturing investigations.
• Effectively leads/facilitates/participates/completes cross-functional team investigations for deviations.
• Utilize tools such as Method 1 and Pfizer Human
• Maintains Quality Systems and ensures that products conform to regulatory, compendial and Pfizer Quality Standards.
• Ability to independently handle complex and detailed situations in multiple areas
• Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives for issue resolution.
• Performance (PHP) tools in the course of the investigations
• SME support during Regulatory audits including contributions to strategies to successfully respond to auditor concerns
• Participates in internal and external GMP audits
• Provides product knowledge and support for regulatory deficiency responses, regulatory annual reports, and the development of other regulatory submission packages.
• Manage a high number of investigations.

Leadership responsibilities

• Pod (area) leader – SME for a specific area, leads weekly pod meetings, mentors and guides colleagues within that area, provides guidance and overall support for each area.
• Training of new colleagues in all areas
• Leading continuous improvement projects
• Updates, authors, and approves standard operating procedures, on the job training records, risk assessments, quality decision memos, etc.

BASIC QUALIFICATIONS

Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and at least 5 years of relevant experience required. 1 year of previous management experience required.

Experience in a cGMP environment, with a strong working knowledge of a variety of Kalamazoo quality systems and processes. 

Demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities. 

Experience in 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. 

Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.

Strong analytical and problem solving abilities.

PHYSICAL/MENTAL REQUIREMENTS

Office position with time in the production environment.

Independently, with minimal guidance, consistently produces quality work.  Must be able to work in a team environment within own team and interdepartmental teams.   Must work under short timelines while maintaining quality work.  Must have effective written and oral communication skills.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional off shift and weekend work. The PPS team is a 3-shift operation. Support of that team on all shifts is expected.

• Other Job Details:
• Last Date to Apply for Job: January 27, 2022
• Eligible for Relocation Package
• Eligible for Employee Referral Bonus

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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