Veranova · 4 hours ago
Associate Director, Quality Assurance - CDMO
Devens, MA, US
Full-time
Onsite
Lead/Staff, Director/Executive
$170K/yr - $190K/yr
10+ years expVeranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. The Associate Director of Quality Assurance is responsible for managing the Quality Assurance group, ensuring compliance with cGMP practices, and leading the development of Quality Assurance personnel.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Evaluate and implement systems, methods, techniques, and solutions to complex quality compliance issues
Host all regulatory agency and client audits
Interface with Clients for project planning, and problem resolution with a strong customer service approach
Recommends and leads implementation of critical compliance systems and provide recommendations to operations management
Recommends the stop of any manufacture and/or distribution of a product if necessary
Manages the review, approval, and delivery of Quality Assurance related training content and programs including new Quality Assurance initiatives for continuous improvement
Analyses trends associated with data, proficiency testing, equipment/supply/reagent defects and develop solutions as appropriate
Directs and advises the Quality Assurance group to achieve long and short-term goals and objectives
Develops, improves, and revises Standard Operating Procedures (SOPs) and Quality Policies as required/needed
Assures the qualification of suppliers and vendor management program
Ensures the review and approval of equipment qualification protocols and results
Participates in internal auditing programs to assure compliance with regulatory requirements and company standards
Partner collaboratively with Production, Maintenance, QC for all Quality decisions
To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed
Qualification
Required
BS or MS in Chemistry or related field required
Must have a minimum of 10 years of experience in Quality Assurance in an FDA regulated industry
Minimum of 5 years of supervisory experience required
Minimum of 10 years in laboratory environment, preferably in API in GMP environment
Must have extensive experience in Analytical and Quality Control support of Active Pharmaceutical Ingredient (API)
Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11
Expertise in FDA regulations, GMPs, and Quality Systems relevant to pharmaceutical manufacturing
Demonstrate attention-to-detail, problem solving, and ability to make decisions quickly
Excellent analytical, written, and verbal communication skills required to demonstrate Strong technical writing and the ability to clearly express ideas
Proven ability to lead and coach, and motivate employees, clearly communicate job requirements, and effectively manage performance of staff
Proven team player with well-developed interpersonal, organizational, mentoring and communication skills, including written documentation
Ability to change priorities in response to company demands while continuing to deliver exceptional work quality
Preferred
Knowledge of SAP, LIMS, Master Control, and project management experience desired
Must be a change agent and have strong interest in learning and applying new techniques
Company
Veranova
Veranova develops and manufactures active pharmaceutical ingredients(APIs).
501-1000 employees
H1B Sponsorship
Veranova has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (17)
2023 (12)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
unknown2022-06-01Acquired
Leadership Team
Mike Riley
Chief Executive Officer
Jose Ibietatorremendia
SVP, General Counsel & Secretary
Recent News
2025-08-01
Company data provided by crunchbase