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Role Summary

This Operations Quality (OQ) position will support the Groton, CT PharmSci Small Molecules OQ department by assisting in quality operations activities related to the manufacture and disposition of GMP clinical drug product. As a Senior Associate Operations Quality colleague, the successful candidate will have quality touchpoints prior to the start of drug product manufacturing through disposition of final drug products for clinical use. Paramount to this role will be acting as a quality point of contact for supporting investigations and ensuring compliance with regulatory and internal standards.

This role does not oversee direct reports.

This role will offer the opportunity to collaborate with partner lines across Pharmaceutical Sciences Small Molecule (PSSM), as well as with other groups within PSSM Operations Quality.

This is a great opportunity for someone to join the Operations Quality team with quality oversite to PSSM drug product manufacturing in Groton CT.

What You Will Achieve

In this role, you will:

• Support for internal Groton CT drug product manufacturing, including quality touchpoints in cleaning validation, master batch records, working batch records, review of executed batch records and final bulk material disposition.
• Help in handling the disposition of clinical Drug Product and intermediates, in support of Groton GMP manufacturing and testing operations, including partnering with key PSSM business lines
• Assist in manufacturing and laboratory quality investigations and quality risk management.
• Support the effective management of changes, quality issues, and investigations, including decisions that may involve complex quality and technical issues or concepts.
• Work with PharmSci Business Line colleagues to define and implement CAPA activities for investigations and follow-up trend analysis.
• Assist in providing OQ guidance and support to new strategic initiatives and goals within Pharmaceutical Sciences Quality Operations, partnering with our business line partners (e.g. SDM & PCMM manufacturing, laboratory) to drive efficiency, compliance, and best-in-class science and operations.
• Provide input into decision-making forums such as PSQRT and AQRT.
• Use risk-management tools to assist in assessing quality issues occurring during drug product manufacturing and testing GMP activities.
• Collaborate with OQ and business-line partners to ensure local processes and quality systems are in alignment with global procedures, internal quality standards, and regulatory requirements.
• Contribute to the development and compliance of OQ and business line partner standard operating procedures via authoring, reviewing and approval.
• Identify opportunities and facilitate continuous improvement solutions to ensure consistency, compliance, and best practice sharing.
• Provide support to inspection readiness efforts, internal and corporate audits, and regulatory inspections as needed.
• Ensure appropriate networking to develop and maintain close and effective business partner relationships with colleagues.
• Ensure adherence to regulatory and internal compliance standards.

Soft Skills Required:

• Good interpersonal, organizational, and communication skills (both oral and written) and demonstrated skills in team matrix working.
• Proven ability to deliver technical reports/presentations.
• Strong demonstrated learning and change agility.
• Ability to innovate new, novel solutions to both new and old problems.

Here Is What You Need (Minimum Requirements):

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;OR an associate's degree with 6 years of experience; OR a high schooldiploma (or equivalent) and 8 years of relevant experience
• Awareness of U.S. current Good Manufacturing Practices (GMP) and EU GMPs with respect to manufacturing and testing requirements for clinical supplies used in phase 1 through 4 clinical trials as demonstrated by work experience

Bonus Points If You Have (Preferred Requirements):

• Relevant work experience in a cGMP pharmaceutical manufacturing, testing and or OQ environment
• Experience with handling GMP compliance issues, resulting from GMP deviations or material/product defects, and participation in quality investigations
• Experience in quality assurance is strongly desired
• Hands-on knowledge of systems such as GDMS, eQMS, EMD, QTS, and LIMS

Non-Standard Work Schedule, Travel or Environment Requirements

Support of off shift (i.e. non-core hours) when necessary, which would require flexible working hours.

OTHER JOB DETAILS

Last Date to Apply for Job: 4/22/25

Work Location Assignment: On Premise

The annual base salary for this position ranges from $80 300,00 to $133 900,00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10,0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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

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