Sr. Specialist Quality Operations (Secondment - 12 Months)

WHY PATIENTS NEED YOU

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. 

WHAT YOU WILL ACHIEVE

This role is a 12‑month secondment opportunity designed for high‑performing Operations and Quality professionals seeking to broaden their experience and gain meaningful exposure to the partner organization. The intent of this assignment is to deepen cross‑functional knowledge, strengthen collaboration between Operations and Quality, and develop future leaders with a strong end‑to‑end understanding of drug product manufacturing and compliance. This posting is for current Kalamazoo Drug Product Operations colleagues who are looking for experience and growth within the Quality organization.

The successful candidate will be fully integrated into the drug product quality organization and will perform the day‑to‑day responsibilities of the role, serving as an active contributor to operational unit, compliance, and continuous improvement initiatives. This is a hands‑on assignment with accountability for delivering results while gaining practical experience working across multidisciplinary teams.

This secondment provides a unique development opportunity to build technical depth, project leadership capability, and regulatory awareness while contributing tangible value to the business through operational improvements and sustained compliance.

HOW YOU WILL ACHIEVE IT

Independently provide real-time Quality impact assessments and decisions on Drug Product issues, such as:

• Ability to handle complex and detailed situations.

• Accurately assess consequences of decisions.

• Accurately assess potential regulatory impacts on a global basis.

• Immediately escalate issues with potential market and/or stability impact.

• Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.

• Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary.

• Utilize tools such as Method 1 and Pfizer Human Performance (PHP) tools in the course of the investigations.

• Participate in QRM assessments that gain approval through Site and Area QO Management.

• Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc. as appropriate.

• Independently assess a wide range of Change Control activities (PTVAs, Protocol development, SOP and MBR changes) to determine potential Quality and Operational GMP impacts.

• SME support during regulatory audits including contributions to strategies to successfully respond to auditor concerns.

• Participates in internal GMP audits.

• Effectively communicate complex technical issues to all levels of Management (including outside of Quality).

QUALIFICATIONS

Must-Have

• Applicant must have a bachelor's degree with at least 3+ years of experience; OR a master's degree with more than 1+ year of experience; OR an associate's degree with 6+ years of experience; OR a high school diploma (or equivalent) and 8+ years of relevant experience.

• Pharmaceutical experience and strong, demonstrated technical skills exhibited in a cGMP environment are requirements.

• Strong oral and written communication skills.  Ability to influence various stakeholders and gain consensus.

• Basic project management skills

• Exposure to and knowledge of Six Sigma and PHP investigational techniques.

Nice-to-Have

• Strong investigational experience.

PHYSICAL/MENTAL REQUIREMENTS

• Job will include standing, walking, and sitting.  Occasional lifting may be required. 

• Job will require being able to gown/dress as needed to support production areas.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Occasional travel may be required for specific projects or training.

• Aseptic gowning training is required. 

• Job may also require occasional weekend/evening work supporting a 24-hour/7 day operation.

OTHER JOB DETAILS

• Last Date to Apply for Job: July 8, 2026

• Additional Location Information: NA

• Eligible for Relocation Package – NO

• Secondment 12 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment.  Please refer to the Fleet Policy and Procedures document for more information.

• There will be no change to your current work location.

• Note: This secondment offers a valuable opportunity for professional growth. It will need to be funded by the secondee’s home market.

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

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.