Manager Quality Operations

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Jul 30, 2021
Ref
4819740
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.

What You Will Achieve

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, 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 problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

ROLE SUMMARY

This position is responsible for Quality Operations (QO) Tech Transfer support within the PGS-Kalamazoo site including technical project implementation and providing Single Point of Contact (SPOC) for QO support and system implementation.  Projects include plant network strategy transfers, new product implementation in Co-development with Research & Development, and internal Continuous Improvement and Organic Growth.

ROLE RESPONSIBILITIES

Familiarity with GMP requirements and industry quality assurance practices and systems. With guidance, coordinate and implement the quality systems integration of a variety of projects, which includes working in the following areas of QO:

Analytical Method Transfer Exercise (AMTE) Support -- Coordinates bringing new analytical methods into the release labs to support the introduction of new products to the site, with a focus on:

  1) Analytical technology capability assessments

  2) AMTE protocol and report authoring

  3) Test Plan creation

CMC-Site Compliance - Preparing the site regulatory submission strategy with key objectives related to:

  1) Regulatory strategy development

  2) Interaction with health authorities including preparation of PAI activities

  3) Process Change Form (PCF) authoring to support new product submissions

  4) Maintain knowledge of product filing to support inquiry responses from internal and external customers

  5) Participates in internal GMP audits and supports customer and regulatory audits, as needed.

QA Floor Support – Integrates new products in the site quality systems. Conducts and reviews non-conformance investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other cGMP functions.  Provides guidance and oversight in identifying root cause and preventative corrective action.  Leads and reviews formal risk assessments.  Releases materials related to project activities.  Activities include:

  1) Strategy development and implementation

  2) Lot Release

  3) Deviation management

  4) Change Control Management

QA Validation Support– Reviews and may help develop product and process validation strategies.  Work with the project team to assure global validation strategies are executed with respect to:

  1) Process Validation

  2) Equipment Validation

  3) Cleaning validation

Raw / packaging material Support – Supports the data gathering, evaluation and release of raw materials, packaging, and Pfizer produced products that conform to corporate, customer, and regulatory standards, with an emphasis on:

  1) New raw material assessment

  2) Test plan maintenance

  2) Lot Release

BASIC QUALIFICATIONS

  • Bachelor’s degree in Chemistry, Biochemistry, Microbiology or related science and at least 6 years of relevant experience in pharmaceutical quality operations required. Candidates with related advanced science degrees and relevant experience may also be considered as follows: Master’s degree with at least 4 years experience or PhD with at least 2 years experience.

  • Experience in a cGMP environment, with a strong working knowledge of a variety of pharmaceutical quality systems and processes including analytical testing, method transfer, deviation investigation, raw and packaging materials, lot release, manufacturing support, process validation, site compliance and project management related to active pharmaceutical ingredients, liquid / semi solids, injectable products and/or vaccines.

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

PREFERRED QUALIFICATIONS

  • At least 5 years experience working in pharmaceutical product transfers

  • Experience in active pharmaceutical product or drug product lot release activities

PHYSICAL/MENTAL REQUIREMENTS

Work primarily performed in an office environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position may require occasional travel, dependent on project needs.

OTHER DETAILS

  • Last Date to Apply: August 9, 2021
  • Eligible for Relocation Package

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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