QA, Sr. Manager

Commonwealth Sciences - Lexington, MA (30+ days ago)


Responsibilities of the QA, Sr. Manager:
Provide leadership to the establishment and maintenance of compliant quality systems, processes and procedures in support of commercial products.
Work directly with operating entities to ensure that products meet all requirements.
Maintain the appropriate levels of GMP compliance and provide quality services.
Oversee the Quality Assurance (QA) programs and activities; this includes management, auditing programs, as well as the review of SOPs, investigations, specifications, methods, reports (analytical and process), product complaints and manufacturing records.
Assist the quality team in the development, establishment and maintenance of internal Quality Systems processes and procedures (e.g., change control, training, audit, management, deviation and CAPA) that complies with applicable GMP standards, regulations and guidelines.
Identify training and development needs for the team and implement them though individual curriculum. Provide feedback to team regarding training to ensure compliance with SOPs and policies
Facilitate resolution of quality issues with internal and external parties in a timely manner. Coordinate communications with vendors and internal team for quality issues.
Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriate.

Requirements of the QA, Sr. Manager:
BA or BS degree in a scientific discipline.
At least 10 years of experience in Quality Assurance at an operational level supporting manufacturing, quality control in a pharmaceutical or biotech environment.
Experience with Phase 3 and/or commercial drug product manufacturing is a plus.
Prior experience related to managing quality systems in technology transfer, scale up and validation.
In-depth knowledge and full understanding of pharmaceutical GMPs
Experience with effectively managing FDA inspection, working with regulators, and supplier audits.
Must have excellent verbal, written, interpersonal, organizational and communication skills.
Demonstrate ability to manage staff and projects (direct and indirectly) and variable workloads with demanding timelines.

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.
To apply for this job, send your resume to jobs@cwsciences.com