Manager Investigations – Quality, Process Tech., and Validation

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Jun 28, 2022
Ref
4858525
Required Education
Bachelors Degree
Position Type
Full time

Why Patients Need You

Provides technical and quality support for Drug Product Manufacturing Technology (DPMT) and Operations. Supports Quality and Operations with investigation of deviations. Performs root-cause analysis, DPMT lead to identify appropriate, effective corrective and preventive actions (CAPAs). Implements CAPAs actions in conjunction with other enabling groups (i.e. Engineering, Maintenance, Quality, Validation, EHS). Identifies and implements process and equipment efficiency, safety, quality and/or cost improvements.

What You Will Achieve

Develops and validates manufacturing processes for drug products, including new or revised dosages or presentations, taking into consideration problems inherent in the transfer of technology from research, other sites, or other areas within the site to production. Conducts tests and measurements throughout the stages of production to determine control over applicable variables. Identifies and implements process and equipment efficiency, safety, quality and/or cost improvements. Identifies and mitigates risks in development, validation, production, quality, and support operations that could negatively impact the safety, identity, strength, purity, and quality of the product.

How You Will Achieve It

Leads quality and technical discussions with Operations, Engineering, and Quality teams regarding resolution of compliance related situations.

Leads effective and on-time CAPAs implementations in conjunction with other enabling groups (i.e. Engineering, Maintenance, Quality, Validation, EHS).

Provides DPMT quality assurance oversight and review and/or approval of registration, integrated product run (IPR) and validation study documents.

Provides DPMT quality assurance review of assigned technical protocols, reports, and study assessments. Ensure GMP requirements are met and appropriate in technical activities conducted.

Provides quality and technical input during the optimization of the use of raw materials, equipment, and personnel in producing compliant products and leads/participates in continuous improvement initiatives.

Designs/plans/supports/leads cGMP training program and onboarding for DPMT colleagues.

Manufacturing floor support in leading investigations and provide compliance support as DPMT lead.

Applies extensive technical and industry-specific expertise and has full knowledge of the requirements of other related disciplines (technical, Regulatory, Quality Assurance, Quality Operations, Project Management, etc).

Support process validation of new products and tech transfer projects

Primary author for reports, presentations, and technical papers with minimal direction.

Reports will contain analysis of Quality, Regulatory and/or Financial impacts where appropriate.

Demonstrated skills in leading investigations (CAPAs), validations, and CMC regulatory relevant discussions and documentation.

Qualifications

Must-Have

  • Bachelor’s degree in Engineering or Pharmacy & with a minimum of 8 years of relevant pharmaceutical industry, OR Master’s degree with a minimum 6 years of relevant pharmaceutical industry experience.

  • Experience in quality and technical investigations related to sterile injectables and other liquid/semisolid formulations.

  • Experience in a cGMP environment including specific knowledge of and experience with Drug Product investigation, manufacturing/processing, and equipment knowledge/familiarity.

  • Ability to support laboratory studies and analyze and interpret data from a variety of sources.

  • Strong aptitude for learning process technology and equipment.

  • Excellent written and oral communication skills

  • Demonstrated ability to interact effectively with all levels of the organization including diverse educational and cultural backgrounds.

  • Flexibility and ability to embrace and lead chance.

  • Ability to work in a high-paced team environment

Nice-to-Have

  • Specific experience or education in Pharmaceutical Regulatory is desirable.

  • Six-Sigma training or other Right First-Time training.

  • Candidate with project management experience or MBA is preferred.

Physical/Mental Requirements

  • Frequent time in manufacturing, lab, and office environments.
  • Must be able to perform gowning requirements for entry in the manufacturing areas.
  • Requires lifting, sitting, standing, walking, stair climbing and roof access.

Work Environment

  • Office environment, with frequent time in the lab/manufacturing areas.
  • Possible exposure to high noise environments, solvents, and pharmaceutical ingredients.
  • Use of hearing and eye protection is required.
  • Must be available to support 24/7 – 365 operation.

Non-Standard Work Schedule, Travel, or Environment Requirements

The focus of the work is at the Kalamazoo, MI site, however 0-20% travel may be required for network support.

Work Location Assignment:On Premise

Other Job Details

  • Last Date to Apply: July 12, 2022
  • Eligible for Relocation Package: YES

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.

Engineering

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