Sr. Director, Site Quality Head

Minaris•Allendale, NJ

16h

About The Position

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.

Requirements

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
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
Strong communication and executive presentation skills
Experience with global quality systems, compliance audits, and regulatory agency engagement

Nice To Haves

Familiarity with GCTP requirements and Japanese regulatory obligations is a plus

Responsibilities

Serve as the site’s senior-most quality authority
Act as the final decision-maker for product quality-related escalations and batch release
Foster a proactive quality culture
Ensure the site is maintained in a constant state of regulatory inspection readiness
Lead preparation, hosting, and response efforts for Health Authority inspections
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)
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
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
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
Ensure data integrity and regulatory compliance across all site activities, including manufacturing, microbiological and bio-analytical testing
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
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