Sr. Manager, Quality Validation
This position’s main responsibility is to provide Quality oversight of facilities, equipment, processes, cleaning, and method validations in a cGMP environment performed for Aimmune at Contract Manufacturing Organizations/Contract Testing Labs, and internal Aimmune computer systems validation. The position will review and approve validation procedures, batch records, protocols/reports, and change controls, as well as provide regulatory requirements for GMP validation activities. Additional responsibilities may include conducting internal/external audits and inspection readiness training. This position provides quality recommendations and guidance to project teams and manages other compliance duties as assigned.
- Provide Quality oversight and leadership for validation activities related to Aimmune products produced at 3rd party CMOs / CTLs.
- Provide Quality oversight and leadership for computer system validation activities at Aimmune related to Aimmune products.
- Manage and coordinate process monitoring and continuous improvement initiatives as related to validation master plans per GMP requirements, as required.
- Participate in providing Quality input for protocol generation, execution, and final package preparation for process, equipment, facility and method validation activities
- Review and approve change controls related to the implementation of process changes, method improvements and equipment upgrades.
- Development and implementation of SOPs/guideline documents with systemic procedural improvements related to validation activities.
- Manage QA review and approvals of validation investigations, qualifications, protocols and reports.
- Manage, oversee, develop, and guide direct reports if applicable and/or contract support personnel.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by Aimmune, validation techniques/approaches and systems utilized at Aimmune.
- Lead and represent QA Validation in multi-departmental meetings & project teams owned by QA Validation.
- Other duties as assigned.
Qualifications / Requirements:
- Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- 7+ years’ experience in a cGMP regulated manufacturing and Quality environment, with exhibited knowledge or proficiency in regulations related to process validation, process sciences and change control.
- Organizational and management skills to communicate to multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience and participation in regulatory inspections presenting departmental functions in audits or regulatory inspections
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
- Understanding and familiarity with global regulatory requirements, guidelines, and recommendations for cleaning and steaming process validation expectations.
- Proficiency with technical summary report reviews required, with exceptional organizational attention to detail.
- Knowledge of industry standards, guidance documents, and global requirements related to cleaning validation is required.
- Training in project management is a plus.
- Ability to utilize computer to perform tasks.
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics is a clinical-stage biopharmaceutical company located in Brisbane, California, in the biotechnology hub south of San Francisco. The company is developing desensitization treatments for food allergies and is currently in Phase 3 trials for its lead product, for the treatment of peanut allergy, in early 2016. For more information, please visit www.aimmune.com.
Aimmune Therapeutics offers a competitive compensation and benefits package.
Aimmune Therapeutics is an Equal Opportunity Employer.
Qualified candidates should forward a resume and cover letter, including a statement of interest, availability, and experience.
Principals only; no recruiters please.