Senior Director, Quality Assurance and Compliance
1 week ago
We are seeking a highly experienced Senior Director, Quality Assurance and Compliance to lead our global quality assurance and compliance efforts. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and leadership.
Key Responsibilities:
- Develop and implement a comprehensive quality assurance and compliance strategy aligned with the company's objectives.
- Lead global quality assurance and compliance teams, collaborating with quality control and operations groups at manufacturing sites.
- Represent the company in interactions with regulatory agencies, including the FDA.
- Provide technical support to facilities and corporate departments, participating in new product development and ensuring quality performance.
- Investigate product complaints, determine probable causes, and implement corrective measures.
- Enhance quality assurance programs and policies, ensuring consistency across manufacturing facilities.
- Responsible for quality assessment and scorecards for third-party manufacturers.
- Organize quality review meetings to present key performance indicators (KPIs) on quality parameters.
- Develop and implement a quality audit program, including internal audits, GMP, suppliers, and third-party manufacturers.
- Provide mentorship, guidance, and support to quality assurance team members.
- Oversee the design, implementation, and continuous improvement of the company's Quality Management System (QMS).
- Drive continuous improvement initiatives across quality processes, leveraging data to identify trends and areas for enhancement.
Requirements:
- Bachelor's or master's degree in a relevant field, such as biology, chemistry, or engineering.
- A minimum of 15 years of quality assurance experience, with a focus on GMPs and substantial operational experience in drug substance or OTC manufacture.
- Experience interacting with US FDA and global regulatory bodies/health authorities.
- Strong organizational skills, with the ability to work in a fast-paced environment.
- Ability to work independently, project manage, problem solve, and find solutions.
- Strong communication skills and a proactive team player in collaborating with stakeholders across multiple departments and management levels.
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