DescriptionReporting to the Director, Quality Control Analytical, the Associate Director, Quality Control will primarily manage Viridian's stability program performed by outside testing laboratories. The Associate Director will manage CMO/CTL, review data and prepare CoA. This position works closely with other functions within Viridian and external CMO/CTLs.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):- Provide strategic leadership to the QC Analytical team, including oversight of external partners to support all stages of program development
- Develop and evolve phase-appropriate specifications, reference standards, and critical reagents in accordance with global regulatory requirements
- Analyze and communicate complex analytical data to internal stakeholders, senior leadership, and external partners
- Establish priorities, lead cross-functional activities, and ensure timely delivery of QC commitments through effective influence and collaboration
- Lead method lifecycle management for QC owned methods including transfers, validations, performance monitoring, improvements and change impact assessments
- Provide strategic and operational leadership for external CMOs and CTLs supporting analytical testing, stability, and product release activities for clinical-stage biopharmaceutical and combination products, including accountability for performance, quality, timelines, issue resolution, and escalation
- Align technical expectations across internal teams and external partners, review data and deliverables, resolve issues, and drive partner accountability
- Identify and escalate analytical, compliance, or execution risks early, with a recommended path forward
- Lead or support deviation, OOS/OOT investigations, and implement robust root cause analysis and corrective actions
- Contribute to CMC regulatory submissions, including IND, BLA, and global filings and regulatory inquiries. Support inspection readiness activities and vendor audits
- Serve as the QC subject matter expert during inspections and regulatory inquiries
- Partner with Quality Assurance, Regulatory Affairs, Manufacturing, and Technical Development to ensure alignment across the product lifecycle
Requirements- Requires a Master's degree with 8+ years of relevant experience or a Bachelor's degree with 10+ years of experience in biopharmaceutical quality control or analytical development.
- Demonstrated experience with QC analytical method lifecycle activities for biologics, including method transfer, validation, performance monitoring, improvement, and expansion to support EU regulatory and market requirements
- Experience working with contract laboratories and external manufacturing partners, including data review, technical issue resolution, and partner oversight
- Experience supporting regulatory inspections and health authority interactions
- Strong technical knowledge of analytical, bioanalytical, and device test methods used for biopharmaceutical and combination products, including ELISA, chromatography (HPLC/UPLC), electrophoresis, spectroscopy, compendial methods, and device functional performance testing
- Experience leading investigations and quality system processes (deviations, OOS, CAPA, change control)
- Proficiency with data analysis tools and statistical methods (e.g., JMP) supporting specification setting and method performance trending and data integrity expectations in regulated environments
- Ability to operate effectively in a dynamic, fast-paced biotechnology environment
- Strong written and verbal communication skills with experience preparing technical and regulatory documentation
- Strong commitment to ethical standards
- Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, SharePoint)
- Ability to travel up to 10%
- The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
- 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
- 401(k) Company Match with immediate company vest
- Employee Stock Purchase plan
- Generous vacation plan and paid company holiday shutdowns
- Various fertility, mental, financial, and proactive physical health programs
