Title: Manager, Quality Assurance
Location: Hobart, NY
Sponsorship: No
Type: Full time, permanent (no contractors or C2C)
Schedule: onsite (no remote)
Salary: Commensurate with experience +10% bonus
Relocation Benefits: Yes
Responsibilities
The Manager oversees, manages, and ensures the successful day-to-day operations of Quality Assurance departments for the company. These departments include QA Operations, QA Label Control, QA Document Control, QA Release, and Quality Systems. The Senior Manager ensures this success of the teams by oversight of the Managers, Supervisors and Individual Contributors:
- Manages employee performance by clearly defining job responsibilities and standards of performance
- Ensures the Quality Assurance groups successfully monitor the quality of all manufacturing and packaging activities
- Ensures the Quality Assurance groups successfully performs batch disposition activities to meet specified time lines
- Establishes meaningful goals and metrics for groups in conjunction with the Site Quality Director, and manages the performance to those goals
- Leads the team that provides Quality Assurance review and approval of deviations
Education:
- BS or BA in Life Sciences or Engineering
Experience:
- Minimum of 7 years' experience in the pharmaceutical or similarly regulated industry, preferably in a QA, QC, Regulatory or Validation related position
- Minimum of 3 years in a Management or Supervisory position
- Excellent oral and written communication skills; excellent organizational skills
- Experience in a DEA regulated environment is highly desirable.
- Extensive knowledge of FDA regulatory requirements applicable to pharmaceuticals. Applies GMP regulations and other international guidelines to all aspects of the position.