cGMP Testing/QC Manager

Overview

Element Ann Arbor has an opportunity for a Department Manager (cGMP Testing) to join our growing team in Michigan. In this role you will be a member of the operational leadership team reporting to the Operations Manager or General Manager and perform a variety of leadership responsibilities within the department to insure timely and accurate test results are delivered. All Operational Leadership positions must be proficient in a number of core business skills including but not limited to compliance to established safety rules, code of conduct, and company policies and procedures.The Department Manager (cGMP Testing) will provide leadership to ensure a seamless transition from validation to sample analysis laboratories, driving the development and sustainment of critical capabilities and implementing enhanced process controls. This role leads a team responsible for both small and large molecule drug analysis, collaborating cross-functionally within the site and across the broader network to develop strategic capabilities that align with the site’s mission and technical objectives. The ideal candidate will possess strong expertise in Quality Control operations and quality systems, with a focus on compliance, process optimization, and continuous improvement.This is an exciting opportunity for an experienced Quality Control and cGMP Sample Analysis Leader to contribute significantly to a growing organization dedicated to maintaining the highest standards in servicing for biologics and small molecule pharmaceutical development organizations around the world.

 

Responsibilities

• Ensure current method validations and proper execution of test procedures, including bioassay methods, binding assays, and small molecule analysis assays, following industry guidelines and client-specific requirements.
• Manage laboratory equipment upkeep, calibration, and preventive maintenance, ensuring proper documentation in logbooks and electronic management systems in collaboration with the metrology and laboratory operations teams.
• Stay updated on compendial changes and ensure compliance with relevant standards, particularly those specific to CROs, CDMOs, and QC operations.
• Manage external client/partner relationships providing laboratory services and materials, ensuring quality and cost-effectiveness while meeting regulatory and contractual obligations.
• Coordinate with Finance to maintain appropriate inventory levels and ensure budget adherence, optimizing resources for timely deliverables.
• Contribute to establishing phase-appropriate specifications that meet regulatory requirements and align with client expectations in a CRO setting.
• Maintain data integrity for all applications and executed work, ensuring high-quality, accurate data generation and reporting.
• Generate protocols, technical reports, and manage QC change controls, test procedure revisions, SOP updates, laboratory investigations, and root cause analyses, ensuring compliance with industry standards and client requirements.
• Escalate critical quality issues to management as needed, ensuring swift corrective actions to mitigate risks and uphold quality.
• Conduct internal audits to ensure cGMP compliance, maintaining a focus on continuous improvement and adherence to quality systems in a CRO environment.
• Write and revise Quality Systems SOPs to maintain regulatory compliance, ensuring alignment with CRO-specific processes and standards.
• Lead training and development for team members to foster a culture of continuous improvement, ensuring all personnel are equipped with the necessary skills for success in a CRO QC role.
• Ensure compliance with health and safety regulations (e.g., OSHA) and maintain a safe work environment, adhering to safety standards specific to laboratory and CRO settings.
• Collaborate with the team to achieve organizational goals and implement strategies, fostering an environment of teamwork and goal-oriented outcomes.
• Lead a team of QC and sample analysts, ensuring resource allocation and day-to-day scheduling for sample analysis and related activities to meet client deadlines and regulatory standards.

Skills / Qualifications

• Bachelor of Science degree in a scientific discipline, advanced degree preferable.
• Proficiency in database, project management, spreadsheet, and word processing software.
• At least 10 years in Quality Control within the biologics industry, with 3 years in a management role.
• Deep understanding of cGMP, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standards.
• In-depth knowledge of quality control principles, GMP, ISO, and FDA regulations.
• Experience in aseptic processing and/or mammalian cell culture production.
• Proven a