Manager QO Aseptic Manufacturing

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.

What You Will Achieve 

The successful candidate will provide individual contributor subject-matter expertise within the Microbiology Department and across the Kalamazoo site in the areas of viable and non-viable environmental monitoring (EM) in classified environments (including ISO classified and controlled non-classified areas). The successful candidate will participate on site-wide project teams and will interact with multiple levels and departments throughout the organization to drive change, assure quality compliance, and ensure the high quality and continued supply of life-saving pharmaceuticals to the market.  It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe. 

How You Will Achieve It  

Complexity and Scope of Responsibility

• Manages multiple projects/ongoing work activities (timelines, work plans, project deliverables) of moderate to high complexity while providing training/coaching and guiding the work of others on the Team.

• Can execute work independently and make decisions with incomplete instructions/information.

• Can lead teams through ambiguous situations.

• Daily workload is largely self-initiated and self-guided. 

• Applies team effectiveness skills and discipline knowledge to contribute to the achievement of work for the site.

• Accomplishes results through contributions to project deliverables, as well as through coaching and mentoring others.

• May guide tactical activities for OTE colleagues and contractors to support project-related operational goals.

• Supports developmental and training opportunities for others on the Team.

• Able to defuse emotional situations.

• Encourages accountability and ownership.

• Ensures team is operating in a manner consistent with cGMPs.

Vision, Strategy, and Business Alignment

Works in concert with others in the Microbiology Department, as well as in other Quality and Operations areas (Project Engineering, QO Validation, Production) to coordinate and complete work per established timelines and quality expectations.

Breadth and Depth of Knowledge

• Demonstrates a breadth and depth of technical/functional knowledge of environmental monitoring, personnel monitoring, and aseptic technique necessary in classified areas and can mentor others on these topics.

• Demonstrates thorough understanding of viable and non-viable EM, regulatory expectations, cGMPs, and understands how these standards relate to current site business operations.

• Has thorough understanding of regulatory expectations and Pfizer standards, principles, theories, concepts and practices as they apply to the departmental area.

• Considered a technical resource for the site.  Will be expected to discuss environmental monitoring and project work in internal (Corporate) and external (Customer and Regulatory) audits and inspections.

• Reviews/approves technical content ensuring both scientific merit and compliance to regulatory agency regulations and Pfizer policy and standards.

• Applies knowledge of internal/external business challenges to provide input into recommendations for improvement to processes or services within their work team.

• Provides technical leadership in investigating processes, deviations, and unit work processes.

Knowledge Sharing

• Actively mentors, coaches, and shares knowledge with others, both internal and external to their assigned Work Team.
• Finds Win-Win opportunities between individuals and within teams.
• Able to effectively resolve issues that may be outside of standard protocol or guidelines.

Impact of Decisions

Decisions may impact the Microbiology Department, Quality Operations, and associated Production areas.

Communication

• Communicates and negotiates effectively across the Site, as well as with external organizations (i.e., regulatory bodies)

• Demonstrates influence & persuasiveness at all levels of the organization.

• Skillfully influences up, down and across the organization by knowing when to be “consistent” and when to be “flexible.”

• Demonstrates highly effective coaching conversations by understanding when a certain leadership style has a high probability of success and when it does not.

• Demonstrates effective written and oral communication skills.

Influencing Others

• Encourages the participation and perspectives of all Work Team members.

• Listens to and explains difficult issues to reach shared understanding and build alignment across the team.

• Mentors others in troubleshooting and brainstorming activities

Managing Change

• Identifies and makes improvements to existing work processes with a thorough understanding of the quality, regulatory, and/or compliance risks associated with the change(s).

• Identifies and removes internal/external barriers that may hinder the success of a change effort.

• Develops an effective feedback loop and acts as necessary to ensure change efforts stay on track and any needed adaptations are made.

• Can apply previous knowledge to unknown situations to affect a productive outcome.

• Understands cultural norms as it relates to interpersonal interactions.

Qualifications

Must-Have

• Applicant must have 10 years of relevant experience;

• OR an Associate's degree with eight years of experience;

• OR a Bachelor’s degree with at least five years of experience;

• OR a Master’s degree with more than three years of experience;

• OR a Ph.D. with 0-2 years of experience.  

• Experience in an industrial and/or aseptic pharmaceutical production environment.

• Thorough understanding of aseptic technique

• Candidate will be required to complete aseptic gowning certification (Grade B) to enter aseptic manufacturing areas

• Thorough knowledge of US, EU, and rest-of-world CGMPs and GLPs for drug products and medical devices.

Physical/Mental Requirements

• Ability to analyze complex data and evaluate microbiological results is required.

• Ability to complete aseptic gowning qualification is required (Grade B).

• Basic computer skills, such as data entry with a high level of attention to detail, are also required.

• Occasional lifting (less than 35 lbs.) and reaching may be required. Extended time working at a computer terminal is also required.

• Long periods of standing, walking, and/or sitting may be needed.

Non-Standard Work Schedule, Travel or Environment Requirements

Primarily First Shift: 7:00 am – 3:30 pm, Monday - Friday.

This role supports 24/7 pharmaceutical manufacturing. On-call, evening, weekend, and/or holiday hours may be required to meet business needs.

Possibility of cross-site support. Travel < 10%.

Other Job Details

• Last Date to Apply: February 6, 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’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.

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