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Director Gmp Manufacturing Jobs (NOW HIRING)

Lonza

Director, Manufacturing

Walkersville, MD · On-site +1

$198K - $232K/yr

Director, Manufacturing Location: This position is currently remote. A future transition to an on ... S. growth investment project, ensuring successful start-up and transition into routine GMP ...

Lonza

Director, Manufacturing

Walkersville, MD · On-site +1

$198K - $232K/yr

Director, Manufacturing Location: This position is currently remote. A future transition to an on ... S. growth investment project, ensuring successful start-up and transition into routine GMP ...

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Director Gmp Manufacturing information

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$69.5K

$141.9K

$209.5K

How much do director gmp manufacturing jobs pay per year?

As of Sep 11, 2026, the average yearly pay for director gmp manufacturing in the United States is $141,872.00, according to ZipRecruiter salary data. Most workers in this role earn between $111,500.00 and $167,000.00 per year, depending on experience, location, and employer.

What are the responsibilities of a director GMP manufacturing?

A Director GMP (Good Manufacturing Practice) Manufacturing oversees the production of pharmaceutical or biotechnology products to ensure compliance with regulatory standards. They are responsible for managing manufacturing operations, maintaining quality systems, and leading teams to achieve production goals. This role involves coordinating with quality assurance, regulatory affairs, and other departments to ensure that products meet safety, efficacy, and regulatory requirements. Additionally, the Director is involved in strategic planning, process optimization, and continuous improvement initiatives within the manufacturing facility.

What are the key skills and qualifications needed to thrive as a director GMP manufacturing?

To thrive as a Director GMP Manufacturing, you need deep expertise in Good Manufacturing Practices (GMP), regulatory compliance, and operations management, typically supported by an advanced degree in life sciences or engineering. Familiarity with quality management systems (QMS), batch record software, and regulatory submission tools is essential. Strong leadership, problem-solving, and communication skills help drive team performance and ensure cross-functional collaboration. These skills are critical to maintaining product quality, meeting regulatory standards, and ensuring efficient, compliant manufacturing operations.

What are some common challenges faced by a director GMP manufacturing, and how can they be addressed?

Directors of GMP Manufacturing often encounter challenges such as maintaining regulatory compliance, managing cross-functional teams, and ensuring consistent product quality in a fast-paced environment. Balancing strict quality standards with tight production timelines requires proactive communication and robust process oversight. To address these challenges, successful directors implement continuous training programs, foster a culture of quality, and establish clear channels for collaboration between manufacturing, quality assurance, and regulatory teams.

What is the difference between Director Gmp Manufacturing vs Manufacturing Manager?

AspectDirector Gmp ManufacturingManufacturing Manager
CredentialsTypically requires a Bachelor's or higher in Life Sciences, Engineering, or related fields; often with GMP certificationsUsually holds a Bachelor's degree in a relevant field; GMP knowledge preferred
Work EnvironmentOversees multiple manufacturing sites or departments, strategic planning, compliance, and high-level operationsManages daily manufacturing operations, team supervision, and process execution
Industry UsageCommonly used in pharmaceutical, biotech, and GMP-regulated industriesUsed across manufacturing sectors, including pharmaceuticals and biotech

The main difference is that the Director Gmp Manufacturing focuses on strategic oversight, compliance, and high-level management within GMP environments, while the Manufacturing Manager handles daily operations and team management. Both roles require GMP knowledge, but the director role involves broader responsibilities and strategic planning.

What are the most commonly searched types of Gmp Manufacturing jobs?

The most popular types of Gmp Manufacturing jobs are:

What are popular job titles related to Director Gmp Manufacturing jobs?

For Director Gmp Manufacturing jobs, the most frequently searched job titles are:

Infographic showing various Director Gmp Manufacturing job openings in the United States as of September 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $141,872 per year, or $68.2 per hour.

Associate Director, GMP Quality Assurance

Redwood City, CA • Hybrid

Revolution Medicines
See more jobs at Revolution Medicinesexternal

Full-time

Posted 24 days ago

Job description

The Opportunity:

The Associate Director, GMP Quality Assurance will provide quality oversight and decision-making authority for development, technology transfe , manufacture, testing, and batch disposition of small molecule Drug Substance (DS) and Drug Product Intermediate (DPI). The role ensures GMP compliance, product quality, data integrity, and inspection readiness for late-stage clinical and commercial programs.

This role will be the primary Quality partner to Technical Operations, CMC, Regulatory, Supply Chain, Analytical Development, and external CDMOs, with end-to-end oversight of DS and DPI manufacturing, quality events, validation, release, and continuous improvement.

Key Responsibilities include:

  • Provide QA oversight and disposition support for clinical and commercial small molecule DS and DPI batches, ensuring compliance with GMPs, regulatory filings, specifications, and internal standards.

  • Review and approve master and executed batch records, specifications, methods, certificates of analysis, and release packages.

  • Review and approve deviations, investigations, OOS/OOT results, change controls, CAPAs, and risk assessments affecting DS and DPI; ensure scientifically sound product-impact evaluations.

  • Lead Quality Governance and operational meetings with CDMOs and contract laboratories to align on manufacturing readiness, issue escalation, release timelines, and performance.

  • Provide QA oversight for technology transfer, scale-up, process validation/PPQ, cleaning validation, analytical method transfer, and continued process verification.

  • Support CMC submissions, inspections, lifecycle changes, and health authority responses.

  • Maintain inspection readiness and the GMP Quality System through SOPs, supplier qualification, metrics, and oversight of critical materials, CDMOs, and laboratories.

Required Skills, Experience and Education:

  • A Bachelor's degree in a scientific or technical discipline is required.

  • A minimum of 10+ years of progressive GMP Quality experience, including late-stage or commercial small molecule DS and/or DPI manufacturing.

  • Quality oversight of CDMOs supporting technology transfer, validation/PPQ, manufacturing, testing, and batch release.

  • Inspection readiness experience in the United States and ex-US markets.

  • Technical knowledge of small molecule process chemistry, process controls, impurity management, analytical testing, specifications, and validation.

  • Knowledge of applicable US and global GMP regulations and industry practices.

  • Experience with deviations, investigations, OOS/OOT, CAPAs, change controls, and risk assessments.

  • Ability to assess complex manufacturing and analytical issues and make risk-based Quality decisions.

  • Strong leadership, collaboration, and stakeholder management skills.

  • Ability to manage multiple priorities, external partners, and aggressive timelines.

  • Sound judgment, attention to detail, self-motivation, and commitment to product quality.

  • Proficiency with Microsoft Office and electronic quality/document management systems.

  • Experience reviewing CMC content for IND/IMPD/NDA submissions and post-approval changes.

Preferred Skills:

  • Commercial DS/DPI disposition and post-approval change experience is preferred.

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