QA Manager, Drug Product

QA Manager, Drug Product Job Description
Just is seeking a highly motivated QA Manager within the Quality Assurance group that desires to be
part of a team focused on improving worldwide access to Biotherapeutics! The role is responsible for
providing Quality oversight for the Drug Product Manufacturing services to ensure adherence to cGMP regulations, Just Quality Requirements, and Regulatory guidelines. This role is the main point of contact for the Client and CMOs for all drug product activities.

Responsibilities
 Independently plan and manage all aspects of tech transfer and fill finish operations for Just –
Evotec Biologics to fill finish CMOs
 Represent the client for review and approval of Quality controlled documents
 Review CMO batch records and provide oversight for all specified manufacturing operations
 Throughout manufacturing activities ensure cGMP compliance and all its related elements in
documentation, reports, and records are maintained
 Collaborate with QC, clients, and CMOs to help author and setup stability studies
 Responsible for creation, review, and signature of Drug Product CoAs (certificate of analysis) and
CoCs (certificate of compliance)
 Works with project team leaders to author, complete, review, and approve proposals and SOWs
(statements of work)
 Responsible for helping the client set up initial communication and contracts with CMOs when
starting a new project
 Work with clients and CMOs to review and approve Quality Agreements
 Ensures all requirements are met and will perform lot disposition for Drug Product
 Works closely with the CMO staff to investigate, document, and resolve compliance issues and
deviations. Ensure deviations are thoroughly identified, defined, and properly assessed
 Works closely with clients to ensure investigations, documents, and any compliance issues and
deviations are communicated appropriately and resolved in a timely manner
 Work closely with Just Quality Assurance (QA) Operations with respect to Drug Product
manufacture, release, inventory management and distribution, and as pertains to vendor
selection, qualification and monitoring and all other activities related to cGMP and ICH
guidelines
 Interact with clients on presentations and project results; will also work closely with clients
during initial and subsequent manufacturing campaigns
 Serve as the Quality representative on cross-functional teams
 Apply advanced theory, technical principles, and expert judgment to independently address a
broad range of problems
 Sign documents for activities as authorized and described by Just policies and procedures.
 Perform tasks as requested by leadership to support Quality oversight activities
 Communicate with finance any invoices or work orders generated from CMO work
 Oversee the shipments of drug substance to CMOs for fill/finish activities
 Provide support to help ship drug product vials for labelling or stability testing
 Support Drug Substance manufacturing if needed

Qualifications and Educational Requirements
 B.S. in Engineering or Science discipline and 5-8 years of GMP biologic manufacturing
experience. Some or all of this experience should be in fill/finish processing.
 Has excellent understanding and knowledge of all fill finish operations including aseptic hand
filling and automated filling of liquid vials. Familiarity with lyophilized DP a plus.
 Has demonstrated track record of managing hands-on cGMP manufacturing operations
 Experience and a thorough understanding of coordinating manufacturing activities with other
departments (QA, QC) to maintain internal and project schedules.
 Creative individual with excellent troubleshooting skills as they relate to scientific and
engineering principles.
 Solid technical understanding of GMP biologics manufacturing processes and equipment.
 The ability to work both independently and collaboratively with scientific and engineering staff
across multiple disciplines in a fast-paced and dynamic environment.
 Strong focus on Quality and attention to detail.

The base pay range for this position at commencement of employment is expected to be $120,000 to $145,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.