Pfizer

Associate Manager - BQ QMS and Compliance

Posted 29 Days Ago

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2 Locations

In-Office or Remote

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Manage pharmaceutical quality systems and compliance for quality control and stability laboratories. Responsibilities include approving method transfer and validation documentation, ensuring cGMP compliance, leading change control, tracking CAPA and metrics, managing LIMS builds, reviewing laboratory data, supporting investigations, participating in audits and safety inspections, recommending corrective actions, and mentoring junior colleagues.

Summary Generated by Built In

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.
What You Will Achieve
In this role, you will:

Create, review, and approve test method transfer and validation protocols, reports, and equipment qualification records.
Maintain compliance with Current Good Manufacturing Practices in Quality Control and Stability laboratories.
Support in investigations and critical assessments.
Change control process owner, tracking CAPA and BQ Metrics.
Manage Laboratory Information Management System builds, and review laboratory data.
Serve on cross-functional teams, conduct safety inspections, participate in audit walkthrough and responses, recommend corrective actions, and train junior colleagues.

Here Is What You Need (Minimum Requirements)

M.Sc. Microbiology with 8+ years of industrial experience with any years of relevant experience
Strong technical skills in Change management, Risk management and Investigations.
Experience in microbiological testing and technical review.
Deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
Detail-oriented with robust knowledge of quality systems
Effective written and verbal communication, as well as interpersonal skills

Bonus Points If You Have (Preferred Requirements)

Relevant pharmaceutical experience
Strong understanding of computer system utilization.
Experience with Laboratory Information Management Systems (LIMS)
Proficiency in data analysis and interpretation
Knowledge of regulatory requirements and guidelines
Strong problem-solving abilities
Effective time management and organizational skills
Ability to mentor and train junior colleagues

Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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

Skills Required

M.Sc. in Microbiology
8+ years of industrial experience
Strong technical skills in change management, risk management, and investigations
Experience in microbiological testing and technical review
Deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
Robust knowledge of quality systems
Effective written and verbal communication and interpersonal skills
Relevant pharmaceutical experience
Strong understanding of computer system utilization
Experience with Laboratory Information Management Systems (LIMS)
Proficiency in data analysis and interpretation
Knowledge of regulatory requirements and guidelines
Strong problem-solving abilities
Effective time management and organizational skills
Ability to mentor and train junior colleagues

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Healthcare Strength — Healthcare coverage is described as comprehensive, with multiple plan options, dental and vision, mental-health services, telehealth, and eligible Pfizer medications at no cost. Family-building benefits such as infertility treatment, adoption, and surrogacy support further reinforce the offering.
Retirement Support — Retirement support includes a 401(k) with employer matching plus an additional company retirement contribution, alongside access to financial-planning resources. This combination is positioned as a meaningful part of total rewards.
Leave & Time Off Breadth — Paid time off includes 15 holidays, three to six weeks of vacation depending on service, and the option to purchase additional vacation weeks, plus dedicated caregiver-leave days. Twelve weeks of paid parental leave and backup care resources add flexibility for family needs.

Learn more about Pfizer's Compensation & Benefits →

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.