POSITION SUMMARY

Leads roll out and oversight of Veeva QMS modules, ensuring compliance with applicable regulatory requirements. Manages the development, implementation, and continuous improvement of policies and procedures to maintain quality standards aligned with global regulatory and company guidelines. Partners cross-functionally to ensure effective execution of quality processes. Applies strong knowledge of global regulations to support compliant and efficient operations. Contributes to the strategic direction and ongoing performance of the Quality Management System (QMS), driving consistency, inspection readiness, and continuous improvement initiatives.

JOB FUNCTIONS/RESPONSIBILITIES

• Lead the end-to-end implementation and rollout of new modules within Veeva, ensuring alignment with business needs and regulatory requirements.
• Serve as the Quality Systems lead and subject matter expert (SME) processes, driving standardization and harmonization across the organization.
• Partner with cross-functional stakeholders (Quality Assurance, Manufacturing, Supply Chain, and IT) to define system requirements, workflows, and business processes.
• Oversee system configuration, user acceptance testing (UAT), and validation activities (e.g., CSV/CSA) to ensure the system is fit for intended use and compliant with global GMP regulations.
• Assist with developing and executing implementation plans, including timelines, resource planning, risk mitigation strategies, and communication plans.
• Author and/or review governing documents (SOPs, work instructions, and training materials) to support the new modules and ensure alignment with QMS requirements.
• Lead training strategy and rollout, including role-based curricula, to ensure successful user adoption and adherence to new processes.
• Monitor system performance and user feedback post-implementation; identify and implement continuous improvements and enhancements.
• Collaborate with internal stakeholders to ensure alignment and effective utilization of newly implemented and current modules.
• Act as the primary point of contact for system-related issues, deviations, and change controls.
• Support internal and external audits and health authority inspections by providing system documentation, demonstrating functionality, and addressing inquiries.

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree in scientific discipline

Knowledge, Skills and Abilities:

• 12+ years’ experience and strong background in Quality and Quality Systems in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations
• Prior experience implementing or supporting electronic QMS platforms, ideally Veeva Vault QMS
• Strong project management and change management skills is a plus
• Ability to drive process standardization and continuous improvement
• Demonstrate a quality mindset and ability to influence across the organization
• Successful experience writing and reviewing SOPs and other Quality documents.
• Expert knowledge of phase appropriate cGxPs and experience leading Quality System implementation and continuous improvement efforts.
• Demonstrated ability to successfully interact with regulatory health authorities at inspections and thorough understanding of audit and vendor management programs.
• Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.

The salary range for this position is $197,129 to $221,404 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY

We are seeking an experienced Director, GMP Quality Assurance (QA) Operations to provide strategic and operational leadership in managing quality for outsourced manufacturing and testing operations, ensuring product quality, regulatory compliance, and reliable supply of clinical material. This role will be a key cross-functional partner, and will work closely with CMC, Supply Chain, Quality Control, and Regulatory teams to drive quality strategy, continuous improvement, and operational excellence. It would be specializing in QA support of late phase development to commercial biologics manufacturing. 

Responsibilities:

• Manage and provide oversight of routine operations conducted by external partners, including CDMOs and testing labs
• Provide timely feedback for GMP quality events and escalate to management for aligned decisions, as appropriate.
• Ensure timely batch record review, product disposition, and compliance with regulatory requirements
• Develop and monitor partner performance metrics, risk assessments, and escalation pathways
• Collaborate with internal CMC, Regulatory, Quality Control, and Supply Chain teams to support technical transfers, process development, and regulatory submissions
• Serve as GMP SME for cross-functional initiatives to strengthen quality systems, enhance compliance, and drive operational efficiency
• Serve as a primary QA representative during regulatory inspections (FDA, EMA, and other global authorities), including hosting inspections, responding to questions, and managing commitments.
• Own inspection follow-up activities, including CAPA development, execution, and effectiveness verification.
• Champion a culture of quality and inspection readiness across internal and external operations

Qualifications:

• Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field
• 10+ years of progressive cGMP Quality Assurance experience supporting biologics manufacturing and analytical testing in a regulated environment, Person in Plant, and direct Inspection experience with domestic and international regulatory agencies
• Direct experience managing external partners/CDMOs and ensuring compliance from clinical supply through validation to commercial supply
• Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance
• This is a hybrid on-site / remote work schedule, with 3 days on-site per week

The salary range for this position is $220,000 to $235,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY

The Associate Director of GCP/GVP/GLP-QA is responsible for supporting Mirum’s clinical study programs as the GCP-QA representative on the study management team; managing activities involving GCP quality assurance and compliance with applicable regulatory requirements; development and implementation of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines. Additionally, this position will support GVP and GLP QA operational activities to ensure data integrity and meeting regulatory expectations and industry standards. 

This position requires experience with global contract research organizations (CROs) and GCP Vendors as well as knowledge of global GCP regulations.

JOB FUNCTIONS/RESPONSIBILITIES

• Achieve established timelines for deliverables.
• QA Representative for assigned Mirum’s Program’s Clinical Study Management Teams.
• Manage/Support BIMO inspection readiness activities
• Support GCP/GCLP/GVP internal audits.
• Provide quality oversite for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs.
• Support GCP, GCLP and GVP Vendor Management/Audit Program. Ad hoc audits may be requested.
• Assist with planning and supporting Clinical Site Management/Audit Program. Ad hoc site audits may be requested.
• Assist with and support regulatory agency inspections for the GCP and PV impacted functions.
• Provide GCP/GCLP/GVP Training as necessary
• Support Quality Management Team (QMT) by providing monthly/quarterly updates based on role and responsibilities
• Support process improvement of QA department, KPI/QPI tracking and oversight.
• Manage GCP/GVP/GLP consultant(s) as needed

QUALIFICATIONS

Education /Experience:

• Bachelor’s Degree in a scientific discipline.
• 10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants.
• Knowledge and demonstrated experience in the applicable GCP regulations, FDA Regulations and Good Clinical Practices, EMA EudraLex Regulations, and ICH Guidelines.
• Strong verbal and written communication.
• Knowledge of basic GVP, GCLP and GLP regulations.

The salary range for this position is $190,000 to $205,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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POSITION SUMMARY

We are seeking an experienced Senior Director, Development Quality (GMP) who will be responsible for providing strategic and operational quality oversight for product development activities from early development through commercialization. This role ensures compliance with global GMP regulations and supports development, scale-up, and technology transfer of drug substance, drug product, and finished product.

This position requires extensive experience in GMP Quality Assurance, including oversight of CMC development, clinical manufacturing, and global supply, along with strong knowledge of regulatory expectations across all phases of development..

JOB FUNCTIONS/RESPONSIBILITIES

• Serve as a strategic Quality leader to support development and advancement of a compliant, phase-appropriate, and collaborative GMP quality culture across development and technical operations.
• Provide QA oversight of product development lifecycle activities, including drug substance (DS), drug product (DP), and finished product (FP) from early development through commercialization.
• Oversee and support GMP quality systems applicable to development, including deviations, CAPAs, change control, investigations, and product complaints.
• Provide QA support for clinical manufacturing, including batch record review/disposition and release of DS, DP, and FP for clinical use.
• Ensure quality oversight of process development, technology transfer, scale-up, and validation activities.
• Support preparation, review, and approval of CMC sections for regulatory submissions (e.g., IND, NDA, MAA) and responses to regulatory authority questions.
• Interface with regulatory agencies and support GMP inspections, including pre-approval inspections (PAIs) and general GMP inspections.
• Identify compliance risks within development and manufacturing activities and escalate issues to appropriate levels of management.
• Oversee and support GMP vendor management, including qualification, auditing, and ongoing oversight of CMOs, laboratories, and suppliers.
• Establish and maintain Quality/Technical Agreements with CMOs and development partners.
• Support new product introduction, acquisition, and integration activities from a GMP quality perspective.
• Support development and oversight of stability programs for investigational and commercial products.
• Develop, track, and trend quality metrics for reporting to Quality Management Review (QMR) and Annual Product Reviews (APR/APQR).
• Ensure inspection readiness across development and clinical manufacturing operations.
• Collaborate cross-functionally with Technical Operations, CMC, Regulatory Affairs, Supply Chain, and Manufacturing.
• Build, mentor, and lead a high-performing Development Quality team.
• Champion a culture of quality and inspection readiness across internal and external operations

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree in a scientific discipline; advanced degree (MS, PhD) preferred.
• 15+ years of experience in the pharmaceutical/biotech industry, including 12+ years in GMP Quality Assurance.
• Strong expertise in global GMP regulations, including FDA, EMA (EudraLex), ICH guidelines, and Good Manufacturing Practices.
• Demonstrated experience supporting product development from early stage through commercialization, including clinical manufacturing.
• Strong knowledge of CMC development, process validation, technology transfer, and manufacturing operations.
• Experience supporting regulatory submissions (IND, NDA, MAA) and health authority inspections, including PAIs.
• Experience with GMP vendor oversight, including CMOs and contract laboratories.
• Proven leadership experience with the ability to build and develop high-performing teams.
• Strong understanding of pharmaceutical supply chain and lifecycle management.
• Experience with inspection readiness and continuous improvement of quality systems.
• Excellent communication, collaboration, and risk management skills.
• Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance

The salary range for this position is $275,657 to $310,847 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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