Senior Director of R&D Quality Assurance
1 day ago
Apellis Pharmaceuticals, Inc. is seeking a highly experienced Senior Director of R&D Quality Assurance to lead our global R&D QA function. As a key member of our Quality Leadership Team, you will be responsible for establishing and implementing the strategy for R&D QA, ensuring compliance with global regulations, and driving quality excellence across our organization.
Key Responsibilities:- Develop and implement R&D QA strategies to ensure compliance with global regulations, ICH guidelines, and industry best practices.
- Lead cross-functional teams to identify and mitigate quality risks, and implement corrective actions to ensure compliance.
- Partner with senior management and stakeholders to develop and implement quality metrics and reporting to ensure transparency and accountability.
- Host and lead regulatory authority inspections, and develop responses to inspection findings.
- Develop and implement Study-Specific Audit Plans and Quality Risk Management Plans for clinical trials.
- Oversee R&D QA incident investigations, and develop and implement corrective actions to address quality issues.
- Minimum of 15 years of experience in pharmaceutical/medical device R&D QA, including at least 7 years in a people management role.
- Strong understanding of R&D Quality for pre-clinical, clinical, and commercial stage work.
- Expert knowledge and experience of implementation of global regulations in clinical trials, pharmacovigilance, product surveillance for medical device and pharmaceutical manufacturing environments.
- Proven ability to build and manage a high-performing team, including attracting, retaining, and coaching top talent.
- A competitive salary and benefits package.
- Opportunities for professional growth and development.
- A dynamic and collaborative work environment.
Apellis is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. We are committed to diversity, equity, and inclusion in the workplace.
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