Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.
At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you’re passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.
Position Summary
The Senior Director, Site Quality Head is responsible for all Quality Assurance (QA), Quality Control (QC), and compliance activities across clinical and commercial manufacturing operations at the assigned site. This leader ensures that all processes adhere to regulatory requirements (e.g., FDA, EMA, PMDA, GCTP), internal standards, and client quality agreements. As a core member of the Site Leadership Team and Global Quality Leadership Team, this role fosters a culture of quality, risk management, and continuous improvement.
For sites exporting to Japan, this role also serves as the Product Security Pharmacist, as required by Japanese GCTP.
Essential Functions and Responsibilities
- Serve as the site’s senior-most quality authority, ensuring that quality principles and standards are fully embedded into all departments and daily operations.
- Act as the final decision-maker for product quality-related escalations and batch release, safeguarding patient safety and regulatory compliance, as direct delegated authority from the CQO.
- Foster a proactive quality culture by promoting accountability, transparency, and operational excellence at all levels of the organization.
- Ensure the site is maintained in a constant state of regulatory inspection readiness, in alignment with global GMP and GCTP requirements.
- Lead preparation, hosting, and response efforts for Health Authority inspections (e.g., FDA, EMA, PMDA) and client audits.
- Collaborate with global and site leadership to implement regulatory strategies and remediation plans where gaps are identified.
- Ensure all site licenses, certifications, and registrations are current and compliant with evolving regulatory landscapes.
- Oversee the implementation and maintenance of a robust Quality Management System (QMS) that includes deviations, CAPA, change control, and document management.
- Lead initiatives to drive continuous improvement in the effectiveness and efficiency of quality systems and governance processes.
- Collaborate with global and site leadership to support the deployment and sustainability of electronic QMS and Laboratory Information Management Systems (LIMS) in line with global standards.
- Collaborate cross-functionally to ensure that validation strategies meet regulatory expectations and support robust lifecycle management.
- Collaborate with global and site leadership to design, implement, and monitor a harmonized site training program that ensures compliance proficiency in GMP, aseptic behavior, documentation, deviation management, and inspection readiness.
- Develop and coach Quality team members to build strong technical and leadership capabilities that align with organizational growth.
- Promote a learning culture where employees are empowered and held accountable for quality performance.
- Establish and lead Site Quality Management Reviews to assess performance trends, escalate critical issues, and drive continuous improvement actions.
- Represent the site in Global Quality Management Reviews, providing transparency into quality metrics, audit outcomes, and regulatory commitments.
- Collaborate with peers across sites to harmonize quality metrics, methods, and processes and ensure alignment to global strategies.
- Prepare, negotiate, and approve Quality Agreements with clients and critical material vendors based on approved global templates.
- Provide strategic oversight for Quality Control operations, ensuring timely and accurate in-process and release testing aligned with regulatory and client expectations (aligned with specific site responsibilities).
- Ensure data integrity and regulatory compliance across all site activities, including manufacturing, microbiological and bio-analytical testing.
Product Security Pharmacist (as applicable)
- Fulfill responsibilities under Japanese GCTP as the Product Security Pharmacist, including oversight of all manufacturing and quality control activities for export products.
- Review deviations and CAPA that impact product quality to ensure mitigation strategies are comprehensive and effective.
- Receive and approve periodic quality reports and audits, ensuring validity of product specifications and consistency of manufacturing processes.
- Act as the liaison with clients in the event of product recall or significant complaint investigations, providing full cooperation and transparency.
Leadership Responsibility
- Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
- Identifies, recruits, and retains top-notch talent.
- Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
- Develop employees to meet both their career and organizational goals.
- Builds strong customer relationships and delivers customer-centric solutions.
- Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
- Comfortable working in ambiguous situations and adaptable to change.
- Must model the highest degree of moral and ethical behavior and maintain confidential information.
- High degree of autonomy and strong decision-making skills.
Knowledge, Skills & Ability
- Strong cross-functional leadership in both line and matrix organizations.
- Able to drive change, manage ambiguity, and build resilient quality systems.
- Demonstrated success in coaching and developing high-performing teams.
- Models the highest ethical standards and decision-making.
- Proficient in root cause analysis, risk management, and regulatory strategy.
Education & Experience
- Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
- 10+ years of senior leadership experience in QA/QC roles within regulated biopharma or ATMP manufacturing.
- Deep knowledge of GMP, aseptic manufacturing, and analytical QC practices.
- Familiarity with GCTP requirements and Japanese regulatory obligations is a plus.
- Strong communication and executive presentation skills.
- Experience with global quality systems, compliance audits, and regulatory agency engagement.
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
The estimated base salary range for each open position based in the United States of America is included for all our current openings. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) as part of the compensation package. Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more
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