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Associate Director Gxp Compliance Jobs (NOW HIRING)

Cabaletta Bio

The Associate Director drives compliance across GxP functions, integrating Critical-to-Quality (CtQ) factors and proportionate, data-driven oversight. Responsibilities Include * Risk-Based QMS ...

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Associate Director Gxp Compliance information

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$42.5K

$128.3K

$199.5K

How much do associate director gxp compliance jobs pay per year?

As of Sep 15, 2026, the average yearly pay for associate director gxp compliance in the United States is $128,297.00, according to ZipRecruiter salary data. Most workers in this role earn between $100,000.00 and $145,000.00 per year, depending on experience, location, and employer.

What does an associate director GxP compliance do?

An Associate Director GxP Compliance is responsible for ensuring that a company's operations adhere to Good Practice (GxP) regulations, such as Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). They oversee compliance programs, conduct audits, develop policies, and train staff to maintain regulatory standards across the organization. This role also involves collaborating with regulatory agencies, investigating compliance breaches, and implementing corrective actions to mitigate risks. Their work is critical in ensuring product quality, patient safety, and regulatory approval within the pharmaceutical, biotechnology, or medical device industries.

How does an associate director GxP compliance typically collaborate with cross-functional teams to ensure regulatory adherence?

As an Associate Director of GxP Compliance, you will frequently work with departments such as Quality Assurance, Regulatory Affairs, Manufacturing, and R&D to interpret and implement regulatory requirements. Collaboration often involves leading compliance audits, developing training programs, and participating in risk assessments to maintain and improve GxP standards. These interactions require strong communication and negotiation skills, as you will help teams understand compliance expectations and resolve any issues. Additionally, you may provide guidance during inspections and contribute to cross-departmental initiatives aimed at continuous improvement.

What are the key skills and qualifications needed to thrive as an associate director GxP compliance, and why are they important?

To thrive as an Associate Director GxP Compliance, you need deep expertise in regulatory requirements (such as GMP, GLP, GCP), quality management systems, and a relevant scientific or pharmaceutical background. Familiarity with tools like Veeva Vault, TrackWise, and audit management systems as well as certifications such as RAC or Six Sigma are typically important. Outstanding leadership, communication, and problem-solving skills set top performers apart in this role. These abilities are crucial to ensure regulatory compliance, mitigate risks, and uphold high standards in life sciences organizations.

What is the difference between Associate Director Gxp Compliance vs Quality Assurance Manager?

AspectAssociate Director Gxp ComplianceQuality Assurance Manager
ResponsibilitiesOversees GxP compliance programs, ensures regulatory adherence, manages auditsManages quality assurance processes, reviews batch records, implements quality systems
CertificationsTypically requires advanced degrees and regulatory certificationsOften requires quality management certifications like CQE or ISO auditor
Work EnvironmentStrategic, compliance-focused, often in regulatory or corporate settingsOperational, hands-on quality oversight in manufacturing or labs

The Associate Director Gxp Compliance primarily focuses on strategic compliance and regulatory adherence at a higher organizational level, while the Quality Assurance Manager handles day-to-day quality processes and operational oversight. Both roles require strong knowledge of GxP regulations, but their scope and focus differ significantly.

What cities are hiring for Associate Director Gxp Compliance jobs?

Cities with the most Associate Director Gxp Compliance job openings:

What are popular job titles related to Associate Director Gxp Compliance jobs?

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Infographic showing various Associate Director Gxp Compliance job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 83% Full Time, 12% Part Time, and 4% Contract. Highlights an 89% Physical, 2% Hybrid, and 9% Remote job distribution, with an average salary of $128,297 per year, or $61.7 per hour.

Director/Senior Director, QMS, Digital QA and GxP Compliance

Waltham, MA

Crescent Biopharma
See more jobs at Crescent Biopharmaexternal

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 19 days ago

Job description

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking a Director/Senior Director, Quality Management Systems (QMS), Digital Quality Assurance and GxP Compliance to be a key leader within Crescent’s Quality organization, responsible for the design, implementation, and oversight of the Company’s Quality Management System (QMS), GxP digital quality platforms, GxP vendor management program, and inspection readiness activities.

You will provide strategic and hands-on leadership to ensure quality systems and computerized/digital systems are fit for intended use, compliant with global regulatory requirements, and scalable to support Crescent’s clinical-stage development programs. You will partner closely with cross-functional stakeholders, IT, and external vendors to ensure appropriate validation, data integrity, vendor qualification and oversight, inspection readiness, and continuous improvement within a highly outsourced operating model.

Responsibilities
  • Provide leadership and oversight for Crescent’s Quality Management System, including document management, training, quality events, and associated digital platforms.
  • Serve as the Quality Business Owner (or designee) for Quality Systems, including implementation, validation oversight, periodic review, and lifecycle management.
  • Ensure QMS and GxP digital systems remain in a validated state through appropriate validation strategies, risk-based approaches, and change control governance.
  • Lead continuous improvement initiatives across quality systems and processes, identifying opportunities to enhance usability, compliance, and efficiency.
  • Provide QA oversight of GxP computerized systems, including validation strategy, periodic reviews, user access reviews, system inventories, and inspection readiness.
  • Lead and oversee Change Control activities related to quality systems and digital platforms.
  • Develop, track, and report Quality System metrics and trends to Quality Management and senior leadership.
  • Ensure effective document control and GxP training management across all functions, supporting consistent adoption of Crescent’s Quality System.
  • Partner with functional teams to support the development, implementation, and maintenance of policies, SOPs, work instructions, and related quality documentation.
  • Lead the development and execution of GxP training strategies, including onboarding, role-based training, and annual refresher programs.
  • Provide oversight of quality system deviations, investigations, and CAPAs, ensuring timely root cause analysis and effective remediation.
  • Support Quality governance forums (e.g., Quality Review Boards), presenting system performance, compliance trends, and risk assessments.
  • Provide QA oversight of vendors and service providers supporting QMS and GxP computerized systems, including qualification, audits, quality agreements, and performance monitoring.
  • Own and lead Crescent’s GxP vendor management program, including coordination of all vendor qualification activities and management of the master audit schedule for GxP vendors and service providers.
  • Ensure Quality Agreements are established, executed, and maintained with GxP vendors where required, partnering with Legal and Procurement as needed.
  • Drive vendor audit CAPAs through to full closure, ensuring timely follow-up, escalation of overdue actions, and verification of effectiveness.
  • Maintain and continuously update the Approved Vendor List (AVL), ensuring accuracy and alignment with current vendor qualification status.
  • Serve as the lead for Inspection Readiness across the Quality organization, ensuring a continuous state of inspection readiness, coordinating mock inspections and readiness assessments, and helping the organization prepare for regulatory inspections or business partner audits and response.
  • Support internal audits and regulatory inspections related to quality systems and digital quality platforms, including inspection preparation and follow-up.
  • Ensure alignment of Quality Systems with evolving regulatory expectations, industry best practices, and Crescent’s stage of development.
  • Contribute to departmental planning, including budgeting for systems, vendors, and resources.
  • Mentor QA staff and external consultants and foster a strong quality culture grounded in accountability, collaboration, and continuous improvement.
  • Stay current on global regulations, industry trends, and best practices related to Quality Systems and digital quality, driving continuous improvement within the QA function.
Education & Experience
  • Bachelor’s degree in a scientific, technical, quality, or related discipline; advanced degree preferred.
  • 8-10 years of progressive experience in Quality Systems and Digital Quality Assurance within biotech or pharmaceutical development.
  • Demonstrated expertise in Quality Management Systems, GxP computerized systems, and data integrity principles.
  • Strong working knowledge of global regulatory requirements and guidance, including FDA, EU regulations, ICH guidelines, GAMP, and phase-appropriate application.
  • Proven experience leading system implementations, validation strategies, and continuous improvement initiatives.
  • Experience providing QA oversight of vendors and outsourced services, including GxP vendor qualification, audit programs, quality agreements, and CAPA management.
  • Experience leading Inspection Readiness programs, including preparing organizations for regulatory inspections and driving cross-functional readiness activities.
  • Demonstrated experience supporting regulatory inspections and internal audits related to quality systems and computerized systems.
  • Strategic, hands-on leader with the ability to balance long-term system strategy with day-to-day operational execution.
  • Strong collaboration, communication, and influencing skills, with the ability to lead cross-functional teams.
  • Ability to thrive in a fast-paced, evolving environment with changing priorities.
  • Commitment to fostering a culture of quality, integrity, inclusion, and continuous improvement.
What We Offer
  • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
  • Competitive compensation, including base salary, performance bonus, and equity
  • 100% employer-paid benefits package
  • Flexible PTO; also, two, one-week company-wide shutdowns each year
  • A commitment to your professional development, with access to resources, mentorship, and growth opportunities
Salary Range
The salary range for this position is $200,000 to $260,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 
 
Additional Description for Pay Transparency:
The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits

Please note:

Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status. 

Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.

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