Manager, CQV Quality Modular Aseptic Processing

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Jul 01, 2022
Ref
4858670
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

What You Will Achieve

The CQV manager oversees the Quality related activities for commissioning, qualification, and validation in the new aseptic manufacturing plant in adherence with cGMP requirements, Quality Standards, and other regulatory requirements. This position is a single point of contact for the project and site teams.

How You Will Achieve It

Ensure Quality commissioning, qualification, and validation targets are met

Provide guidance on the qualification activities and deliverables required and the necessary technical support pertaining to quality matters

Ensure that the systems installed are adequately qualified and comply with regulatory and site requirements

Responsible for QA review and approval on qualification and cGMP documentation for the project

Liaise with C&Q team and Project teams on qualification and quality aspects

Point of contact within the Project to liaise with Kalamazoo site regarding commissioning and qualification related quality issues and procedure updates

Lead / support projects; internal and external audits as required

Qualifications

Must-Have

BA/BS plus a minimum of 5 years of experience in a Pharma, science, or engineering related field, or 10+ years of experience in a Pharma, science, or engineering related field.

Nice-to-Have

Desired technical competencies include:
Knowledge of Regulatory and Industry GMP Standards
Decision Making
Presentation Skills
Coaching & Facilitation
DMAIC, Method 1, human error reduction tools
Leadership skills, communication skills (both written and oral), and ability to interact effectively with all levels of the organization is required.
Knowledge of GMP requirements, Quality Standards, and other regulatory requirements is necessary.

Physical/Mental Requirements

Must be self-motivated and willing to learn new and changing responsibilities.

Non-Standard Work Schedule, Travel, or Environment Requirements

This position may require occasional weekend/evening work supporting a large project. Periodic travel may be required.


Work Location Assignment:Flexible

Other Job Details

  • Last Date to Apply: July 15, 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.

Quality Assurance and Control

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