Manager/TL Quality Operations

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Jan 05, 2022
Ref
4831473
Required Education
Bachelors Degree
Position Type
Full time
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.

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

What You Will Achieve

Leads a team to ensure that the Audits and Inspections and Annual Product Review/Stability Reporting meet defined quality standards and objectives. This position acts ensures inspection readiness at the site.  The role provides input for the development of site strategies, in order to ensure compliance with global regulatory expectations.

Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes.  Fosters teamwork and colleague development, as well as change management, within the department and the function. 

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.  Influences corporate policies through partnership with decision-makers, and acts as a resource to network partners, in the areas of APPRs, stability, and internal and external audits/inspections.

How You Will Achieve It
  • 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)

  • Oversight of internal and external audit program

  • Understand regulatory requirements and audit strategy

  • Provide backup support to APRR and Stability SMEs during inspections

  • Review and approve cGMP Documentation to assure compliance with regulatory requirements

  • Review and approve cGMP Changes in accordance with

  • Review and approve training to assure cGMP requirements are met

  • Manage Resources to meet organizational goals

  • Understand site financial systems

  • Understand Safety concerns and maintain safe environment (5S, ergonomics)

  • Ability to perform GAP assessments for new & revised PQS

  • Ensure participation in company-wide knowledge exchanges

  • Ability to drive change as required by the organization

  • Coordinate generation of APRR data for product reviews

  • Coordinate generation of stability data for internal stability reports

  • Influence to drive outcomes on initiatives with network-level impact, including through negotiation, brainstorming, advocacy, and development of compromise.

Qualifications

Must-Have

BS in Chemistry, Biochemistry, Microbiology, or related science and at least 8 years of relevant experience, particularly in quality or compliance roles.  Candidates with related advanced science degrees and relevant experience may also be considered as follows: Master’s degree with at least 6 years experience or PhD with at least 3 years experience.

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

  • Experience with internal audit programs and/or regulatory inspections

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

  • Experience in aseptic processes and operational knowledge

Other Job Details

  • Last Date to Apply: January 19, 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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