Senior Manager, Quality Validation

Title:                                   Senior Manager, Quality Validation
Reports To:                        Head of Quality
Location:                            Redwood City, CA
Classification:                    Exempt
 

Overview:   

The Senior Manager, Quality Validation is responsible for ensuring validation and technical activities for clinical program development and commercial product lifecycle management at Coherus BioSciences are performed in compliance with corporate and regulatory requirements. This role covers validation of manufacturing processes including DS, DP, labeling and packaging operations as well as computer system validation both internally and across the contract organization (CO) network. This role has accountability for the Coherus validation program including validation master plans, standards for validation documentation and standard operating procedures (SOPs).

Principle Responsibilities and Duties:

• Develop and enhance the Coherus validation program to ensure alignment with regulatory expectations. 
• Provide training and guidance to Quality and Manufacturing personnel on relevant policies and SOPs
• Review and approve validation documents, plans, protocols, and reports (internal and external) to ensure compliance with applicable regulations (e.g. 21 CFR Part 210-211), international guidance documents and standards.
• Serve as the Quality single point of contact to provide technical guidance to internal and external partners to ensure validation activities are aligned with Coherus standards/expectations.
• Support the change control program with respect to facility, equipment, process 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.
• Assist in the identification, development, and implementation of new technologies to implement best practices 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 experience required. Minimum of 5 years qualification and validation experience  preferred.
• Detailed knowledge of Drug Substance, Drug Product and Aseptic Manufacturing processes and application of GxPs (21 CFR Part 210-211) and/or Device GMPs (21 CFR Part 820), EU GMPs (Annex 1).
• Knowledge of System Development Life Cycle concepts and software (GAMP5 expected pharmaceutical standards, 21 CFR Part 11, Annex 11).
• Prior experience working in matrixed environment is required
• Must possess excellent organizational and deductive reasoning skills. Strong communication and written skills are required. Working knowledge of MasterControl or similar records management application and Microsoft Office products, including Word, Powerpoint and Excel is preferred.
• Must possess the ability to work independently to meet project timelines and manage assigned work in alignment with organization and company goals. 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.

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.