Director Quality Assurance (Americas)
Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases.
At Aegerion, we believe that our employees are our strongest asset. We strive to recruit high performing, best-in-class candidates who possess a proven track record of success. We seek candidates who are patient-centric, passionate, entrepreneurial-minded, and interested in joining a high caliber and collaborative team. Our culture offers a kind, energetic, high-growth, and fun environment that provides an unmatched opportunity for individual contribution and development. We emphasize the ability to make an indelible difference within the organization and in the lives of our patients. Aegerion’s headquarters are in Cambridge, MA, and the company trades on the NASDAQ Stock Exchange under the ticker: AEGR.
Note to recruitment agencies: While Aegerion is hiring for several key positions, we are not accepting candidate referrals from any agencies or recruiters at this time. Any resumes received from search firms and/or individual recruiters will be considered unsolicited.
Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans
The Director, Quality Assurance (Americas) is responsible for quality and compliance oversight of manufacturing, packaging, testing and distribution operations in North and South America that support global distribution of Aegerion products. This includes oversight of active pharmaceutical ingredient (API) manufacturing operations as well as dosage form manufacturing operations. Familiarity with international current good manufacturing practices (cGMPs) and other best practices for pharmaceutical manufacturing operations will be a critical component of this role.
- Primary Quality contact/interface with Contract Manufacturing Organizations (CMOs) that are based in North and South America but that provide products and/or regulated services globally
- Responsible for release of drug substance and drug product as well as any raw materials or intermediates, as required
- Responsible for assessing and approving deviations and investigations
- Responsible for coordinating analytical method transfer activities
- Responsible for reviewing and approving analytical method and process validation protocols and reports
- Responsible for organizing and executing audits of CMOs and suppliers of critical materials as needed
- Responsible for developing Quality Technical Agreements and maintaining them in a current state
- Primary contact with Country Managers regarding quality matters
- Responsible for serving as man-in-the-plant when needed
Qualifications and Experience
- Minimum BS degree in a scientific discipline (e.g., biology, chemistry, engineering, etc.)
- At least 8 years quality experience working in an API and/or dosage form commercial manufacturing, packaging and testing environment
- Familiarity with cGMPs a must
- Experience working with CMOs and contract laboratories
- Ability to think intuitively and problem solve
- Team player with excellent oral and written communication skills
- International experience a plus
Qualified candidates are encouraged to submit a resume and cover letter to Human Resources in care of firstname.lastname@example.org