Job Description

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
The Quality Operations Manager assures compliant manufacturing procedures, equipment, and facilities in the new aseptic manufacturing plant Module 2 in adherence with cGMP requirements, Quality Standards, and other regulatory requirements. This position is part of the project team designing and building MAP (Modular Aseptic Processing), the new aseptic facility.

How You Will Achieve It
The MAP project is the new aseptic manufacturing facility. This project is designing and building a new facility from the ground up. All equipment, facilities, and processes are being designed from the ground up. This role interacts with corporate and site SMEs and leadership in order to deliver a successful project. The QO Manager would serve as the Quality SME with GMP input and guidance for the following:

• 
  Design of facility, equipment, and aseptic manufacturing processes to ensure the highest quality products made to strict adherence to current GMP regulations.
• 
  Design a zero deviation process.
• 
  Environmental monitoring methods and controls
• 
  Sterilization programs and validation
• 
  Cross-contamination and foreign material exclusion from the aseptic process
• 
  Consistency of strategy across the MAP project teams
• 
  Lead operational readiness activities to implement quality systems, programs, business processes and procedures. Track progress and communicate status.
• 
  Lead and participate in Quality Risk Assessments.
• 
  Provide Quality input to support project or operational design decisions.
• 
  Build organization according to hiring strategy that supports project milestones.
• 
  Act as a site resource for decisive resolution to concerns in the qualification and commissioning process.
• 
  Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies.
• 
  Develop strategies in support of regulatory inspections and site audits.
• 
  Provide technical mentorship to colleagues

Additional Duties and Responsibilities Include:
Functional/Technical Knowledge:
Knowledge of applicable technical standards, techniques, principles, theories, concepts, production processes, and industry practices/standards.
Knowledge of basic leadership principles.
Focus is on defining and designing processes.

Problem Solving and Innovation:
Provide solutions to a variety of design challenges.
Refers to policies and practices for guidance.

Discretion, Latitude, Level of Independence:
Works under general supervision.
Follows established procedures.
Recommends actions.
Work is reviewed for soundness of judgment, overall adequacy and accuracy.
Must be change agile and flexible in support of a capital project.
Operates within established HR policies and basic colleague relations guidelines.

Teamwork/Influence:
Primarily interactions are with on-site and off-site colleagues.
Potential for global travel to support the project on an as needed basis.
May assist in training less experienced team members.

Qualifications
Must-Have

• 
  Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience
• 
  OR Associate\'s degree with 8 years of experience
• 
  OR Bachelor\'s degree with at least 5 years of experience
• 
  OR Master\'s degree with more than 3 years of experience
• 
  OR a PhD with 0+ years of experience.
• 
  Pharmaceutical or manufacturing experience and strong, demonstrated leadership skills exhibited in a cGMP environment are desired.
• 
  Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.
• 
  Successful candidate must be familiar with tools and techniques required to implement compliance projects through multi-disciplinary teams.

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.
• 
  Prefer 3-5 years of experience with competence in aseptic processing and aseptic behaviors.
• 
  5+ years experience of working in Pharmaceutical Quality Assurance in cGMP manufacturing environment and/or 3-5 years in Medical Device Industry is preferred
• 
  Experience in pharmaceutical start-up from design and development to commercial
• 
  Clean room experience in both gowning and oversight.
• 
  Knowledge and application of medical device and combination products
• 
  Experience participating in regulatory submission projects preferred
• 
  Pharmaceutical or manufacturing experience and strong, demonstrated leadership skills exhibited in a cGMP environment are desired.
• 
  Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.
  Successful candidate must be familiar with tools and techniques required to implement compliance projects through multi-disciplinary teams.

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.

Other Job Details

• Last Date to Apply: April 20, 2023
• Eligible for Relocation Package: Yes

Relocation assistance may be available based on business needs and/or eligibility.






































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\xe2\x80\x99s 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
#LI-PFE