Senior Manager, Quality Assurance; QA)

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Full Time - Salary Devens, MA, US

Senior Manager, Quality Assurance (QA)

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Every role at Veranova plays a part in delivering an exceptional customer experience through ownership and integrity.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

Role Overview:

The Sr Manager, QA is responsible for leading the Veranova Quality Assurance team, managing quality oversight of the manufacturing process and associated operations. This includes leading and managing multiple QA teams for batch record review, batch disposition, and on the floor QA support to ensure GMP compliance across all stages of manufacturing, as well as disposition and release of starting materials and customer facing Quality program leads for each client.

The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards. The role is expected to build strong collaborative relationships with internal and external stakeholders to drive compliance and continuous improvement of GMP operations.

The position is 100% on site 1st shift at our Devens, MA facility.

Core Responsibilities:

Evaluate and implement systems, methods, techniques, and solutions to complex quality compliance issues.

Interface with Clients for project planning, and problem resolution with a strong customer service approach.

Lead or support 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 ensures delivery of Quality Assurance related training content and programs including new Quality Assurance initiatives for continuous improvement.

Analyzes trends associated with data, proficiency testing, equipment/supply/reagent defects and supports development of solutions as appropriate.

Direct and advise 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.

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, and QC for all Quality decisions within the scope of the role.

• Additional assignments/ duties to support team objective and contribute to the Veranova mission may evolve based on business needs.

Qualifications:

BS or MS in Chemistry, Engineering or related field required.

Must have a minimum of 10 years of experience in Quality Assurance in an FDA regulated industry. Experience in an API in GMP environment is preferred.

Minimum of 7 years of supervisory experience required;
Proven ability to lead and coach, and motivate employees, clearly communicate job requirements, and effectively manage performance of staff.

Must have established 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.

Experience with hosting and/or regulatory facing inspection responsibilities is required.

Knowledge of Inventory Management, LIMS, Quality Management software systems experience…