Position: Senior Director/Head of Quality
Position Level: Senior Director
Reports to: VP Regulatory
Overview of Position:
Responsible for the Quality Management System for Equillium, including: providing strategic and operational leadership for all quality related activities, as well as developing, implementing and promoting Equillium’s quality program for GCP, GMP and GLP activities. The incumbent will develop, implement, prioritize, and communicate the company’s quality strategy and its quality programs, including quality assurance and quality management throughout the organization.
As such, the Senior Director/Head of Quality plays a key role in enabling Equillium to achieve its business objectives, both in respect of existing products and in the identification, assessment, acquisition and development of new products.
Essential Duties & Responsibilities:
- Build a stage-appropriate quality team, hire appropriate personnel, and manage consultant team members.
- Manage and implement Quality systems. Manage and oversee SOPs, policies, training and vendors and vendor qualification processes. As appropriate, select, implement, and maintain a suitable software system to support quality related activities.
- Conduct ongoing review of quality and assessment metrics, including development of mitigation strategies as needed and communicate quality metrics to senior leadership on a regular basis.
- Work with clinical development, drug safety and regulatory affairs staff to ensure that all activities, whether performed by Equillium or contract organizations, are conducted in compliance with applicable GCP requirements.
- Work with technical operations and manufacturing staff to ensure that clinical supply and planned commercial manufacturing activities are conducted in compliance with applicable GMP requirements.
- Be responsible for the review of batch records and release of clinical trial material lots and products, and the review of incident/deviation reports and change controls related to manufacturing/quality processes.
- Develop, implement and monitor compliance with quality agreements established with vendors and partners.
- Ensure that the company and all company sites, vendors and clinical trial sites are prepared, for inspection by regulatory authorities.
- Provide post-regulatory agency inspection support and follow-up as required.
- Perform or oversee internal and external audits, ensuring compliance with company policies, procedures and applicable regulations.
- Review and approve audit reports and Corrective and Preventive Actions (CAPAs).
- Report compliance-assessment metrics and updates to senior clinical, regulatory, and quality-management personnel.
- Promote the company’s quality programs to its customers and employees.
- Develop and implement employee communication and training programs in connection with quality objectives, strategies and processes.
- An advanced scientific degree
- RAPS / RAC desirable
- 15+ years experience leading oversight of and/or responsibility for Quality teams and activities across a range of GxP development functions within the biotech/pharmaceutical industry for both drugs and biologics with 7 years of specific leadership and management experience.
- Experience designing and implementing quality systems, including development of policies and procedures, work instructions, auditing, change management and quality training.
Skills and Attributes:
- Expertise in Quality and Compliance, including preparations for BLA and NDA submissions, manufacturing and batch release and commercialization
- Demonstrated experience preparing for and hosting GxP quality audits, regulatory inspections, etc.
- Strong leadership competencies and strategic business perspectives required, to ensure that compliance practices are fully integrated throughout all clinical studies, clinical development and post-marketing activities
- In-depth understanding of the global pharmaceutical drug development and regulatory environment, particularly within the FDA and EMA
- Effective leader – able to work across all levels of the organization, including coaching and mentoring employees, directing consultants and communicating regularly with executives
- Thorough understanding of the manufacturing batch review and release process (GMPs), especially in the contract manufacturing organization setting
- Able to design and execute vendor audits, as well as internal audits
- Ideally, a history of active involvement with joint ventures, highly collaborative partnerships, and in/out-licensing of business opportunities.
- Ability to assimilate and interpret trends in the US healthcare policy environment that directly affect business decisions in the pharmaceutical/biotech industry
- Proven interpersonal and influencing skills. This includes a demonstrated ability to use an open and supportive communication style and to work cross functionally with multiple corporate sites, partners, vendors, teams and personalities.
- Excellent oral and written communications skills.
- Commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
- An entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, attitude and approach
- The ability to think strategically as well as execute tactically
- Ability and strong desire to work in a dynamic “start-up” environment and be able travel from time to time domestically and/or internationally