What are the responsibilities and job description for the Associate Director, Technical Operations Compliance position at Viridian Therapeutics, Inc.?
At Viridian Therapeutics, 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 VP, Device Development & Commercialization, the Associate Director, Technical Operations Compliance is crucial to ensuring the successful development and commercialization of Viridian’s products. This position is responsible for managing the compliance of the Technical Operations department to applicable laws, regulations, and industry standards. The Associate Director Technical Operations Compliance will collaborate closely with Quality Assurance (QA) to ensure completion of relevant Quality Events, including Device Design Control, Change Control, Corrective and Preventative Action (CAPA), Deviation, and Investigation processes.
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):
- Serve as Subject Matter Expert (SME) on Viridian’s electronic Quality Management System (eQMS) within Technical Operations
- Manage Technical Operations deliverables to Viridian’s eQMS. Ensure that all documentation is accurate, complete, and compliant with regulatory requirements
- Ensure proper use of Change Controls from new product introduction (NPI), development, clinical supply, commercial manufacturing and life cycle management
- Facilitate Device Design Control deliverables, through all phases of development including Inputs, Outputs, Verification, Validation and Design Transfer
- Track and trend change control and CAPA effectiveness, using data-driven insights to drive continuous improvement in quality systems and processes
- Lead cross-functional teams to conduct thorough investigations, determine root causes, and implement effective change controls and CAPAs
- Serve as department expert on Risk Management tools
- Collaborate with QA to streamline processes, enhance documentation, and optimize Quality systems for efficiency and effectiveness
- Ensure alignment between Technical Operations and QA on quality goals, standards, and expectations
- Support joint Quality audits and inspections, representing Technical Operations
- Represent Technical Operations during the Quality Management Review (QMR) process
- Identify and implement opportunities for continuous improvement to optimize product quality and manufacturing efficiency
Qualifications:
- 10 years of experience in the biotechnology or pharmaceutical industry, with a focus on monoclonal antibody (mAb) products
- Bachelor’s degree in scientific or engineering discipline required
- 5 years of experience in a technical or compliance leadership role, with experience in change control, CAPA, deviation, and investigation management
- Strong understanding of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Device Design Controls and other relevant regulatory requirements
- Proven track record of supporting successful product launches and commercialization
- Experience with drug-device combination products
- Experience with Veeva Vault and eQMS, or similar software systems
- Demonstrated strong written and verbal communication skills
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Strong attention to detail
- Ability to work in a fast-paced environment and to handle multiple tasks
- Strong commitment to ethical standards
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
- 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 coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
- Fertility and mental health programs
- 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 mental, financial, and proactive physical health programs covered by Viridian
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.
