Senior Manager / Associate Director of Quality Operations

Location
27704, Durham
Posted
Mar 08, 2021
Required Education
Bachelors Degree
Position Type
Full time

Piper Life Sciences is actively seeking a Senior Manager / Associate Director of Quality Operations to join a well-established biopharmaceutical company in the Raleigh / Durham area. This person will be responsible for supporting the cGMP manufacturing operations for commercial products in a CMO environment. This role will be responsible for interacting with clients as well as support the product lifecycle.

Responsibilities of the QA Sr. Manager / Associate Director

·       Provide direction to the Quality Supervisors and Managers in support of the master and executed batch record reviews/approvals for all the commercial programs, shop floor QA oversight as well as the Deviation/CAPA system.

·       Comfortable coaching and mentoring direct reports and specialist as well as aiding in the development of training materials for Quality Systems.

·       Own the Deviation/CAPA quality system and provide compliant investigations, reviews, and approve investigations on an as needed basis.

·       Attend operational meetings that will be in support of Manufacturing operations and batch disposition activities.

Requirements of the QA Sr. Manager / Associate Director

Bachelor's degree and 10 + years' experience or master’s degree and 8+ years' experience or Ph.D. and 6+ years' experience in a QA or CGMP environment in biopharmaceuticals or equivalent.

·       Previous experience supporting quality systems to include deviations/CAPAs and change controls along with 4+years of supervisory experience.

·       Must understand FDA, EU, ROW, and cGMP regulations.

Compensation and Benefits of the QA Sr. Manager / Associate Director

·       Compensation: $95-$120 Sr. Manager; $125-$160K Associate Director – based on previous role and salary.

·       Benefits: Medical, Vision, Dental, 401k, and generous PTO.