Senior Manager, Quality Control

Manager, Quality Control

The Manager, Quality Control leads daily operations of the analytical testing laboratory, ensuring raw materials, in-process samples, and finished products meet established quality and regulatory requirements. In this role, you serve as a hands-on technical leader with deep technical expertise in analytical chemistry, laboratory operations, data integrity, and a proven track record of applying Lean production methodologies to drive efficient, compliant, and right-first-time testing.

This role has primary responsibility for the effective, compliant, and efficient operation of the analytical QC laboratory and the quality of analytical data supporting raw materials, in-process materials, and finished products. The position requires sound technical judgment and the ability to manage complex laboratory operations, investigations, analytical methods, and quality systems within a highly regulated GMP environment. Erroneous or delayed decisions may result in testing delays, product quality concerns, regulatory risk, or significant business impact. Success in this role requires deep analytical chemistry expertise, strong knowledge of laboratory quality systems and data integrity, demonstrated Lean experience, and the leadership capability to develop a high-performing QC organization.

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline.

• 7+ years of experience in a GMP-regulated analytical QC testing laboratory.

• 3+ years of progressive supervisory or management experience.

• Direct experience authoring, reviewing, and closing Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations.

• Demonstrated experience supporting, reviewing, or leading analytical method validation, verification, and transfer protocols within a regulated environment.

• Strong experience with Chromatography Data Systems (CDS), including data integrity, audit trail, and user access controls; hands-on administration experience preferred.

• Proven track record leading complex laboratory investigations, with advanced technical writing skills and proficiency in structured root-cause analysis methodologies to implement effective CAPAs and prevent recurrence.

• Deep understanding of FDA/global regulatory guidance on handling OOS test results and data integrity principles (ALCOA+).

• In-depth knowledge of ICH, USP, and FDA guidelines regarding the validation, verification, and transfer of analytical procedures.

• Ability to apply Lean principles to the validation process—such as using standard templates, defining clear stage gates for method transfers, and reducing the cycle time from development to routine execution.

• Strong verbal and written communication skills with the ability to effectively collaborate across Quality, Analytical R&D, Manufacturing, Regulatory, and other cross-functional teams.

• Strong analytical, organizational, problem-solving, and project management skills with the ability to manage multiple priorities independently.

• Master's or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.

• Advanced experience administering and maintaining Chromatography Data Systems, including audit trail review, user access, and data integrity controls.

• Experience with Lean laboratory transformation initiatives, including 5S, Visual Management, Value Stream Mapping, standard work, and waste reduction.

• Experience optimizing analytical methods to improve robustness, reduce testing time, and minimize solvent or reagent consumption.

• Experience evaluating internal versus external laboratory testing strategies and associated cost-benefit considerations.

• Experience supporting regulatory inspections and customer audits as a technical SME for analytical QC operations.

• Experience partnering with Analytical Research & Development and external laboratories on analytical method development, validation, verification, and transfer.

The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.