DescriptionReporting to the Executive Director of Quality Control, the Director of QC Analytical will lead teams responsible for critical QC Analytical functions, including Method performance, method transfer, specification, Reference standard/critical reagent management, supplier oversight management of key quality systems for respective areas. This role will partner closely with internal stakeholders and external organizations to develop, implement, and continually improve operational strategies while maintaining full compliance with applicable quality and regulatory requirements.
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
- Collaborate closely with CMC functions, including Analytical Development and Process Development, to ensure aligned QC support
- Lead method lifecycle management for QC owned methods including transfers, validations, performance monitoring, and improvements
- Provide strategic oversight for late phase reference standard implementation and ongoing lifecycle management
- Provide oversight of specifications throughout product lifecycle
- Analyze and present data, present to both internal and external stakeholders
- Ensure QC deliverables are met and provide leadership/professional development for team
- Oversee external partners (e.g., CMOs, CTLs) to ensure adherence to quality and regulatory expectations
- Support regulatory submissions by authoring and reviewing relevant CMC sections
- Prepare QC personnel for inspection readiness, support vendor audits, and serve as the QC subject matter expert during inspections
- Oversee quality records within assigned areas, including robust management of OOS/OOT investigations and related deliverables
RequirementsQualifications:- Require a BS, MS, or PhD in a life science discipline with a 12+ years of relevant industry experience
- Strong background in analytical methods and data analysis, including compendial methods
- Demonstrated leadership experience in QC operations and oversight of external CMOs/CTLs
- Deep knowledge of cGMP, ICH, FDA, and EU regulations and guidance
- Proven hands-on experience with analytical methods including but not limited to SEC, icIEF, CE-SDS, Peptide mapping, Potency and compendial methods as well as functional device testing
- Strong people leadership skills, with experience coaching, developing, and managing staff at various levels
- Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- Ability to travel up to 5%
- 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
