Manager of Quality Assurance

We are seeking a Manager of Quality Assurance to lead the strategic development and operational management of our site's ISO 9001-certified Quality Management System (QMS).

The successful candidate will be responsible for ensuring consistent and harmonized execution of quality systems across multiple production lines, QC groups, and R&D teams.

Key responsibilities include:

• Developing the QMS strategy and establishing quality procedures to support RUO production and R&D activities
• Leading and hosting customer audits and ISO 9001 surveillance audits
• Managing the site's supplier qualification lifecycle
• Negotiating and managing Customer Quality Agreements (CQAs)
• Partnering with R&D teams to support new technology development and tech transfer
• Providing cross-site quality leadership for QMS lifecycle maintenance, raw material management, and final product release
• Applying Quality by Design principles to define robust control strategies for manufacturing processes
• Overseeing and managing the execution of quality systems during daily production activities
• Presenting updates to project or upper management teams on progress and enforcement of quality improvement and manufacturing support activities

Requirements:

• Master's degree in a life sciences-related field with 5+ years of QA/QC experience in a biotech production environment
• Experience with molecular biology product manufacturing (oligonucleotides, synthetic gene, mRNA) or formulation services is highly desirable
• Completed Lead Auditor training or deep working knowledge of ISO 9001:2015 standards
• Extensive experience hosting external customer audits and filling out supplier quality questionnaires
• Experience drafting and negotiating Quality Agreements with clients
• Expert knowledge of quality risk assessment, CAPA management, and change control methodologies
• Proven track record in establishing or optimizing a quality organization and working collaboratively with R&D, production, and QC groups

Benefits:

• Medical, dental, and vision insurance
• 401(k) & Retirement Savings Plan (RSP)
• Short Term Disability Insurance
• New Child Leave
• Paid Time Off
• Paid Company Holidays per year
• Paid Sick Days (earned based on hours worked)
• Compassionate Leave
• Jury Duty Leave
• Float day
• Personal days
• Free colleague meals during shift
• Onsite massages
• Onsite gyms