Manager Quality Compliance

About the role

Reporting to the Director, Quality Operations, the Manager, Quality Compliance will support end-to-end product complaint management for Viridian’s externally manufactured and distributed products. This role is responsible for complaint intake, investigation coordination, complainant follow-up, quality metric reporting, and general QA Operations support while partnering with internal teams and external manufacturers, laboratories, device suppliers, and distribution partners to ensure timely, compliant, and inspection-ready complaint handling. The role strengthens Viridian’s product complaint process by ensuring complaints are assessed, investigated, documented, trended, and closed in a timely and compliant manner across internal functions and external partners. This role is based in Waltham, MA headquarters; office-based employees are expected to work in the office three (3) days a week.

Responsibilities

• Manage end-to-end product complaint activities from intake, triage, investigation coordination, documentation, closure, and complainant follow-up in accordance with Viridian procedures and applicable regulatory expectations.
• Serve as the primary QA owner for complaint records, including timely assessment, escalation, investigation assignment, documentation accuracy, closure readiness, and linkage to related quality events, as applicable.
• Coordinate complaint investigations with external manufacturers, testing laboratories, distribution partners, device suppliers, and internal stakeholders for biologic, combination product, and distribution-related complaints.
• Ensure investigations assess product impact, patient safety, device performance, lot history, retain/sample evaluation, distribution/shipping factors, and complaint trends, as applicable.
• Manage complainant, reporter, affiliate, and partner follow-up, including information requests, sample/replacement coordination, response documentation, and complaint status or closure communications.
• Develop, maintain, and report complaint quality metrics, including volume, aging, closure timeliness, recurrence, safety referral status, product/device trends, and partner responsiveness.
• Prepare complaint summaries, trends, and metric updates for Quality Management Reviews, partner governance forums, leadership updates, and inspection/audit readiness.

Requirements

• 5+ years of Quality Assurance experience in the biotechnology, pharmaceutical, biologics, or medical device industry.
• Bachelor’s degree in Life Science or Engineering.
• Strong experience working with CDMOs in a virtual environment.
• Experience with biologics, medical devices, or combination products preferred.
• Previous product complaint handling experience in a regulated biotechnology, pharmaceutical, biologics, medical device, or combination product environment.
• Demonstrated strong written and verbal communication skills, including the ability to communicate clearly with internal stakeholders, external partners, and complainants.
• Proven mindset of proactive continuous improvement.
• Efficient independent worker with ability to focus and drive for results.
• Strong knowledge of US and global GMP regulations, ICH guidelines, and industry best practices.
• Experience using Veeva Quality Management System or a comparable eQMS; direct Veeva experience is preferred.
• Strong analytical and problem-solving skills with a proactive continuous improvement mindset.
• Excellent attention to detail, organizational, and time management skills.
• Ability to work independently and collaboratively in a fast-paced, team-oriented environment.
• Strong commitment to ethical standards.
• Proficient with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint).

Benefits

• Competitive pay and stock options for all employees.
• Medical, dental, and vision insurance.
• 100% Paid Parental Leave.
• Short- and long-term disability coverage.
• Life, Travel, and AD&D insurance.
• 401(k) Company Match with immediate company vesting.
• Employee Stock Purchase plan.
• Generous vacation plan and paid company holiday shutdowns.
• Various fertility, mental, financial, and proactive physical health programs.