Description:
At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team's expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the Director, Quality Operations, the Associate Director, Quality Operations will lead quality oversight of Viridian's external manufacturing and supply network supporting EU and international operations. The role provides hands-on oversight of batch record review, lot disposition, deviations, change controls, suppliers, commercial supply, and international expansion. The Associate Director, Quality Operations will act as the primary quality liaison for CMOs, CDMOs, testing laboratories, distributors, and logistics partners and support batch certification by Viridian's contracted Qualified Person (QP).This role is fully remote and may be located in the United States or the United Kingdom. Travel to US headquarters for meetings may be required at the discretion of management.
Responsibilities:- (including, but not limited to):Provide quality oversight of external partners supporting drug substance, drug product, packaging, labelling, testing, distribution, and logistics activities
- Serve as a primary quality liaison with external manufacturing and testing partners, including routine governance, issue escalation, and performance monitoring
- Perform batch record reviews and lot dispositions in accordance with established procedures
- Review and oversee product- and lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs)
- Own supplier qualification, requalification, performance monitoring, and related Quality Agreements across the external vendor network
- Negotiate, approve, and maintain Quality Agreements with CMOs, CDMOs, testing laboratories, distributors, and logistics partners
- Establish and track KPIs for CMO, CDMO, and supply chain quality performance and escalate trends through Quality Management Review
- Oversee distribution and third-party logistics quality, including cold-chain management, shipping-lane qualification, and assessment and disposition of temperature excursions
- Provide quality oversight of serialization, labeling, and artwork controls
- Support the contracted QP by reviewing complete batch certification packages and resolving certification-related questions
- Review and approve controlled documents supporting manufacture and testing, including master batch records, specifications, analytical methods, protocols, and reports
- Support new product introductions, commercial launch readiness, and ongoing GMP readiness across EU and international manufacturing and supply chain operations
- Ensure compliance with internal quality systems, including document control, training, and audit readiness
- Assist with regulatory inspections and internal audits, including resolution of observations and implementation of corrective actions
- Lead continuous improvement initiatives across quality assurance and external manufacturing oversight processes
Requirements:- Requires a Bachelor's degree in life sciences, engineering, or a related discipline
- Requires 10+ years of Quality Assurance experience in the biotechnology and/or pharmaceutical industry
- Strong experience providing quality oversight of CMOs, CDMOs, and external supply networks
- Experience supporting batch disposition, deviation investigations, change control, and commercial launch activities
- Strong knowledge of EU and UK GMP and GDP requirements, relevant US regulations, ICH guidelines, and global industry best practices
- Familiarity with EU batch certification requirements and supporting a contracted Qualified Person
- Proficiency in electronic Quality Management Systems such as Veeva, TrackWise, or equivalent
- Experience with combination products
- Cold-chain qualification and temperature-excursion assessment experience
- Serialization and FMD implementation experience
- Excellent written and verbal communication, attention to detail, and organizational skills
- Ability to work independently and collaboratively in a fast-paced, team-oriented environment with a strong commitment to ethical standards
- Proficiency with Microsoft Office, including Word, PowerPoint, Excel, Outlook, and SharePointAbility to travel up to 20% internationally, including visits to CMOs, other external partners, and Viridian offices
- Proven mindset of proactive continuous improvement
- 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&D401(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
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws.
Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc. participates in E-Verify, the federal program for electronic verification of employment eligibility.
Employee Type: FT Exempt
