Associate Director, Clinical Quality – EU
Location: Maidenhead, England
Department: R&D Quality EU
Quality is our primary guiding principle at Zogenix. It is the foundation on which all functions and activities are performed. Excellence in the management of Quality is fundamental and the foremost aspect upon which the Pharmaceutical Operations team are judged by our patients, caregivers, partners, colleagues, and regulatory bodies. Our commitment is to go beyond compliance and operate effective development, operations and supply systems that result in excellent products, processes, innovations, and documentation to ensure satisfaction from all stakeholders. We are committed to providing therapeutic solutions with potential to transform the lives of patients and their families living with serious rare diseases. The Quality function within the Pharmaceutical Operations (PharmOps) team is responsible for integrating, executing, and inspiring Quality throughout all functions at Zogenix.
The Associate Director, Clinical Quality Assurance is responsible for development, governance and management of GCP and ensuring other product development and pharmacovigilance activities comply with applicable international and national standards, regulations and guidelines. The incumbent will provide support and promote collaboration internally to ensure all systems, processes and their outcomes remain compliant. The position may provide quality oversight of post marketing studies, based on company goals.
MAJOR AREAS OF RESPONSIBILITY
- Collaborate and/or lead cross functional working groups to assess QMS processes (e.g. processes and issue management) to mitigate GCP quality and compliance issues.
- Monitor and improve the QMS with a focus on GCP aspects
- Investigate, escalate, and/or oversee quality issues including CAPAs and closures including defining and monitoring key quality metrics in support of management reviews.
- Support internal stakeholders in the development of GCP compliant processes, including creation and revision of SOPs and training programs for GCP.
- Ensure involvement of Quality in late stage (post marketing) program development through collaboration with Medical Affairs, PV, etc to influence effective processes and program oversight.
- Participate in support of regulatory inspections and partner diligence audits in cooperation with multiple internal functions as well as external vendors/3rd Parties. Includes training and support for site inspections as well as CROs and service providers.
- Perform routine audits of clinical investigator sites and vendors, and review TMFs and CSRs as assigned
- Serve as QA representative on clinical study development teams; participate in the review and approval of clinical trial “essential documents” (e.g. protocols, ICF, etc )
- Oversee GCP audit activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity.
- Maintain a contemporary knowledge of current regulatory agency and industry trends, standards, and methodologies as related to role
- Represent CQA in assigned projects and cross functional teams and be an advocate for quality and regulatory compliance
- Minimum Education requirement of a BSc/MSc or equivalent in a relevant scientific related discipline
- In‐depth knowledge of and ability to interpret and apply GCP, GPvP, GCLP, EU, FDA and ICH regulations, guidelines, and best practices
- 7+ years’ experience in clinical quality assurance ensuring sponsor oversight including performing GCP audits for late stage pharmaceutical companies
- Strong HA inspection experience with FDA, MHRA, EMA, and/or PMDA is desirable.
- Possesses a thorough knowledge of GCP's and other relevant regulations in US and EU.
- Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice and Good Pharmacovigilance.
- Ability to lead cross-functional teams, manage multiple priorities while maintaining quality and GCP compliance objectives.
- Excellent interpersonal communication skills and strong team skills.
- A working knowledge of databases, including Electronic Document Management Systems (EDMS), is highly desirable
SPECIAL WORKING CONDITIONS
- Travel (domestic and overseas) up to 40%