Sr. Specialist Quality Operations (Secondment - 12 Months)

Pfizer

Kalamazoo, Michigan

JOB DETAILS
SKILLS
Analysis Skills, Auditing, Biotech and Pharmaceutical, Business Operations, Change Control, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Drug Manufacturing, Drug Products, Environmental Regulations, Federal Aviation Regulations (FARs), Federal Laws and Regulations, GMP (Good Manufacturing Practices), Government, Healthcare Providers, Internal Audit, Leadership, Operational Communications, Operational Improvement, PHP Scripting Language (PHP Hypertext Preprocessor), Policy Implementation, Presentation/Verbal Skills, Process Improvement, Production Support, Project/Program Management, Regulations, Risk, Six Sigma, Six Sigma Black Belt, Six Sigma Green Belt, Standard Operating Procedures (SOP), State Laws and Regulations, Willing to Travel, Writing Skills
LOCATION
Kalamazoo, Michigan
POSTED
7 days ago

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.

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.  This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email 

disabilityrecruitment@pfizer.com

. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

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.

Quality Assurance and Control

About the Company

P

Pfizer

A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
COMPANY SIZE
5,000 to 9,999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1849
WEBSITE
http://www.pfizer.com