The Senior Director, Clinical and Safety Quality Assurance will serve as a strategic leader in the development, implementation and management of quality and compliance to ensure clinical related activities are conducted in accordance with applicable global regulations. The individual will partner with senior management and stakeholders to develop a phase and systems-appropriate quality strategy for Apellis' scope of business.
The Senior Director, Clinical and Safety Quality Assurance will work independently and as an effective and engaged team member in a fast-paced environment. This position requires a balanced approach to developing and executing GCP operations while working in a collaborative manner with peers across departments.
Key Responsibilities Include:
- Provide overall GCP quality assurance leadership and strategic development for global clinical trial activities internally, at investigator sites and service providers to ensure collaborative team involvement and implementation of quality and compliance initiatives.
- Manage GCP and GVP QA staff, including recruitment, performance management, hiring, training and development.
- Develop and implement global GCP Quality strategies for global Phase I - IV clinical studies and commercial product, including establishment and maintenance of phase appropriate quality systems; proactively identify and mitigate quality risks.
- Assist in the implementation of GCP compliant procedures and operations to ensure a robust quality management system for the conduct of clinical studies and marketed pharmaceutical/medical device combination products.
- Serve as a resource to global clinical and safety personnel on compliance issues, preparations for external inspections, regulatory risk, and process improvement opportunities.
- Review regulatory and corporate compliance risks, altering senior management when needed.
- Develop and/or oversee appropriate clinical and safety Quality metrics and reporting on compliance to senior management regarding critical quality and compliance related issues and corrective actions to mitigate risk.
- Assure the quality and integrity of the results from raw data protocols and reports are in compliance with investigational plans, policies, procedures, and applicable government regulations.
- Assure global regulations are followed for clinical trial and commercial product reporting, including submission of adverse events/SAE reporting.
- Function as a member of the Quality Assurance Leadership Team to help define strategy and direction.
- Assure personnel, documentation (protocols, reports, device labeling, promotional and advertising materials), processes and quality standards meet expectations for regulatory submissions, regulatory authority inspections, and compliance with applicable regulations and guidelines.
- Oversee the internal and external clinical and safety audit programs, including the development of audit plans, priorities and schedules.
- Manage competing priorities to meet departmental and organizational targets and timelines.
- Deliver leadership and technical direction in preparation and hosting of Health Authority Inspections internally, at clinical sites, and at CROs, including follow-up efforts, to ensure successful outcomes and responses to any observations.
- Oversee clinical trial and safety quality event investigations, including input and approval of plans for resolution of issues, partnering with internal and external stakeholders to ensure CAPAs are appropriate and effective.
- Develop and implement Quality Risk Management Plans for clinical trials and safety.
- In collaboration with functional area leaders, ensure clinical and pharmacovigilance service providers comply with the applicable quality program and regulations/guidelines, and are prepared for Regulatory inspections.
- Proactively provide consultative support to global clinical development activities to protect patient safety, maintain data integrity, and support operational efficiency.
- Any other duties as required.
Skills, Knowledge & Abilities:
- Minimum of 15 years pharmaceutical and/or medical device GCP experience including at least 5 years in a people management role.
- Strong understanding of GCP and PV Quality for pre-clinical, clinical, and commercial product.
- Expert knowledge and in-depth experience of implementation of global regulations in clinical trials, pharmacovigilance, product surveillance for medical device and pharmaceutical manufacturing environments.
- Experience implementing and ensuring quality oversight, auditing, electronic systems management, global inspection readiness.
- Proven ability to build and manage a high performing group, including attracting, retaining and coaching top talent.
- Experience leading/hosting regulatory authority inspections and developing responses to regulatory authority inspection findings.
- Proven experience in successfully developing and implementing Quality Risk Management Plans for clinical trials and safety.
- Experience working with contracted service providers.
Benefits and Perks:
Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!
We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.