Director of Quality Assurance
POSITION OBJECTIVE: The Director of Quality Assurance serves as the leader of all Quality Assurance activities for GMP manufacturing for Athenex’s US multiple manufacturing facilities. Will provide guidance on challenging quality related issues, oversee all regulatory and customer audits and leads with the site staff on strategic projects, and communicate quality issues to Regulatory Authorities. Will also be responsible for managing the development and adherence to all quality management systems, development and implementation of reporting metrics as well as fostering strong working relationships between Quality and Operations.
Essential Job Functions/Responsibilities
- Develops and executes a quality assurance road map that includes resource requirements (including technical solutions, human capital, CapEx, training, etc.) to meet operational business initiatives.
- Support compliant systems for all commercial in-house manufacturing operations.
- Development, implementation, and maintenance of quality improvements, including quality systems and documentation.
- Responsible for generating documentation and communicating quality issues to FDA and other Regulatory Agencies including submission of Field Alert Reports and Recall documentation
- Acts as Quality lead for Contract Manufacturing customers
- Improves and enhances quality standards and strategies to meet both regional and international requirements alongside team members.
- Involved in the disposition of all quality related issues as they impact manufactured product, utilized raw materials and analytical testing to assure released products possess the required potency, purity, and conformance to established specifications.
- Ensures operations meet the necessary regulatory registrations in accordance with state, federal and global requirements.
- Hosts site visits from customers and regulatory bodies for the purposes of auditing/inspecting site compliance. Develops responses and corrective actions based on relevant audit observations and engages site subject matter experts for support.
- Develops and maintains a system for reporting site metrics in accordance with regulatory and site management requirements. Drives discussion with Quality Review Board for establishing a roadmap for strategic quality improvements and priorities.
- Promotes and implements training, motivation, mentorship, and career development opportunities for quality team members.
- Supports and maintains safety, environmental and waste disposal programs from a quality perspective.
- Other responsibilities as may be defined.
Required Education & Qualifications
- Bachelor of Science degree in Biology, Chemistry, or related life science field; advanced degree in life sciences field or MBA is a plus.
- Minimum of 12 years of experience in progressive Quality Assurance and/or Quality Control roles in the pharmaceutical organization
- Minimum of 5 years of experience leading Quality teams of a pharmaceutical organization
- Knowledge of both national and international markets (specifically, the US and EU).
- Strong experience with and knowledge of cGMP, GLP and GCP Quality Management Systems, including 21 CFR 210/211/820 Quality Systems and knowledge of Global Quality regulations
- Direct and positive experience in communicating with regulatory authorities, customers, and executive leadership.
- Experience in sterile drug product manufacturing in strongly preferred.
- Strong, dynamic leadership, communication, and presentation skills with the ability to mentor and develop high performing teams
- Experience leading CAPAs, investigations, root cause analysis and process improvement.
- Lean Six Sigma experience.
- Must be available for 20% travel – some could be national.
- Must have a valid driver’s license to travel between local manufacturing and company site locations.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.