The Quality Validation Manager will be responsible to ensure all commercial quality and technical activities, including validation are performed in compliance with corporate and regulatory requirements. This role covers manufacturing process, packaging, and computer system validation both internally and externally across the CMO / CPO network.
Principle Responsibilities and Duties:
- Review and approve Validation documents, plans, protocols, and reports used in support of activities (internal and external) to ensure compliance (e.g. 21 CFR Part 210-211)
- Administer and maintain risk based, quality driven procedures and practices with respect to engineering and qualification validation. Develop and enhance validation programs to reflect current, best practice regulatory expectations and support the business model and objectives for Coherus.
- Serve as the technical expert for Quality, provide guidance and review of external validation activities to ensure that CMOs are meeting Coherus standards/expectations in support of Coherus product pipeline.
- Support the change control program with respect to facility, equipment, and cleaning validation changes. Support the Information Technology change control program for computerized systems. Evaluate validation impact of manufacturing process changes, equipment upgrades, deviations and product nonconformance events.
- Support the investigations program with respect to engineering, qualification, and cleaning validation related investigations, including trending and corrective and/or preventative actions.
- Attend onsite visits to contractors and where needed, equipment manufacturers to support validation activities.
- Establishes Validation Program, inclusive of Validation Master Plans and standards for Validation Documentation, plus corollary SOPs. Provide training/guidance to Quality and Manufacturing personnel on relevant policies and SOPs.
- Assist in the identification, development, and implementation of new technologies to meet best practice expectations in the Manufacturing and Laboratory environments. Provide technical support for system owners and administrators for various facility systems, manufacturing equipment, and laboratory instruments.
- Ensure timely, efficient and effective communication and/or interaction with regulatory agencies, internal GxP partners, external contract providers or external contracting organizations. Provide timely and effective completion of relevant activities in support of regulatory filings, production schedules and/or customer needs with respect to facilities, equipment and computer system validation.
Experience, Education, Training, Traits:
- Minimum of a Bachelor's degree (or equivalent) in scientific related field and 10 years of experiencerequired. Minimum of 5 years qualification and validation experience strongly preferred.
- Detailed knowledge of Aseptic Manufacturing, working knowledge of Pharmaceuticals GxPs (21 CFR Part 210-211) and/or Device GMPs (21 CFR Part 820), EU GMPs (Annex 1) and the ability to assess compliance risks.
- Knowledge of System Development Life Cycle concepts and software (GAMP5 expected pharmaceutical standards, 21 CFR Part 11, Annex 11).
- Must have strong leadership and management skills with experience forming and leading high performance teams.
- Must possess excellent organizational and deductive reasoning skills. Strong communication and written skills are required. Working knowledge of MasterControl and Microsoft Office, including Word and Excel is preferred. Must demonstrate the ability to multi task by performing multiple projects and tasks simultaneously. Must be able to work and interact well with other employees at all levels.
- Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.