Viridian Therapeutics, Inc. English

Associate Director, Quality Operations Location

Remote - Waltham, MA, United States

Base Pay

$163,000.00 - $200,000.00 / Year

Job Category

Quality

Employee Type

FT Exempt

Required Degree

4 Year Degree

Travel

20%

Manage Others

No

Minimum Experience

10 Years

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 SharePoint

Ability 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&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 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.