Associate Director, Quality Assurance – Facilities Mgmt.
Skills
- Extensive knowledge of cGMP quality systems related to facilities, equipment, and utilities maintenance.
- Experience with deviation, CAPA management and root cause analysis.
- Expertise in maintenance management systems like Blue Mountain RAM.
- Strong communication and interpersonal skills.
- Ability to manage and develop a team effectively.
- Working knowledge of qualification and validation of facilities, utilities, and equipment.
Responsibilities
- Provide QA leadership and oversight for Facilities Management ensuring qualified/validated GMP compliance for facilities, utilities, and equipment.
- Approve maintenance procedures, work instructions, work records, and calibration plans.
- Manage deviation and CAPA processes related to Facilities Management.
- Ensure maintenance and qualification of equipment, utilities, and facilities are maintained during maintenance work.
- Oversee training and qualifications for personnel involved in Facilities Management processes.
- Review and approve planned and unplanned maintenance work requests and escalate trends appropriately.
- Manage and audit the maintenance management system (e.g., Blue Mountain RAM).
- Write, review, and approve deviations, CAPAs, and change controls associated with Facilities Management.
- Develop and maintain Key Quality Performance Indicators related to facility management.
- Set team objectives aligned to business goals and manage employee development and performance.
- Participate in inspections and audits as assigned.
Education
- Bachelor's degree in engineering (mechanical or electrical) or scientific field (microbiology, chemistry, biochemistry).
Benefits
- Generous vacation and company-observed public holidays.
- Volunteer days.
- Long-term incentives and employee stock purchase plans.
- Wellbeing benefits.
- Fitness reimbursement.
- Tuition sponsorship.
- Professional development plans.
Average salary estimate
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Founded in 2010 and headquartered in Novato, California, Ultragenyx Pharmaceutical is a clinical-stage biotechnology company practicing treatment of diseases and debilitating metabolic genetic diseases.
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