Title: manager, quality validation
Reports to: senior vice president, pre-commercial quality assurance
Location: redwood city, ca
Classification: exempt
Overview:
The quality validation manager will be responsible for validation and technical activities supporting clinical and commercial programs, are performed in compliance with corporate and regulatory requirementsThis role covers validation of manufacturing processes, packaging and computer system validation internally and 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.g21 cfr part 210-211).
Administer and maintain risk based, quality driven procedures and practices with respect to engineering and qualification validationDevelop 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, process and cleaning validation changesSupport the information technology change control program for computerized systemsEvaluate 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 sopsProvide 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 environmentsProvide 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 organizationsProvide 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 requiredMinimum of 5 years qualification and validation experience strongly preferred.
Detailed knowledge of drug substance, drug product and 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 skillsStrong communication and written skills are requiredWorking knowledge of mastercontrol and microsoft office, including word and excel is preferredMust demonstrate the ability to multi task by performing multiple projects and tasks simultaneouslyMust be able to work and interact well with other employees at all levels.
Ability to read and interpret complex business and/or technical documentsAbility to write comprehensive reports and detailed business correspondenceAbility to work with groups of people such as other departments and communicate known conceptsAbility 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 dateThis 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 remoteIf 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.
