Senior Manager, Quality Assurance (QA)

Senior Manager, Quality Assurance (QA)

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 desired.
• Must be a change agent and have strong interest in succession planning and professional development of their team(s); Ability to change priorities in response to company demands while continuing to deliver exceptional work quality through leadership by example.

Salary Range:

The salary range for this role is $155,000-$175,000. This range represents a good-faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range.

All full-time employees are eligible to participate in our annual incentive bonus program. Bonus targets vary by career level and are based on individual and company performance.

Our Commitment:

• Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
• Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.

For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to [redacted] in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

All your information will be kept confidential according to EEO guidelines.

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