Associate Director, Quality Control Technical Services

Vericel Corporation • Burlington, MA

2h • Onsite

About The Position

The Associate Director, Quality Control Technical Services will be a key role to ensure there is a harmonized analytical, regulatory, and release testing approach across products, projects and departments as it relates to Quality Control (QC). This role will also contribute to and/or approve analytical specifications, method qualifications and method transfers into Quality Control, method validation and control of critical materials by working with Process and Analytical Development to deliver results, projects and continuous improvement to QC processes and methods across both the Cambridge and Burlington facilities.

Requirements

• Bachelor’s degree in microbiology, molecular biology, biochemistry or a related discipline with 8+ years’ industry experience or MS with 6+ years’ industry experience in cGMP lab environment, or equivalent.
• Strong knowledge of cGMPs and Quality Systems.

Nice To Haves

• Minimum of 8+ years in cell culture, microbial and/or molecular assays.
• Knowledge of cGMP/ICH/FDA/EU regulations.
• Strong initiative and scientific leadership; work with limited direction in a fast-paced environment.
• Collaborative team player who fosters open communication and builds relationships with stakeholders.
• Strong analytical, organization, and communication skills with a positive attitude.
• Strong project management skills.
• Strong knowledge of statistical software and principles.
• Strong background on data integrity.
• Knowledge of Laboratory Information Management Systems (LIMS).
• Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
• Proficient in Outlook, MS Word, Excel and lab based data management systems (LIMs).

Responsibilities

• Leads and serves as the primary Quality partner with Analytical Development to support the move of test methods out of the development space and into the GMP space, lifecycle aspects of test methods over time, and provides final review/approval of qualification activities into QC.
• Owns and drives changes in the analytical control strategy and test methods over time, as well as the execution of the validation strategy for test methods.
• Oversees and ensures execution of method monitoring, including creation, implementation, and routine execution of this program over time.
• Acts as the primary quality control approver for test methods, qualification, and validation activities (including but not limited to protocols and reports, qualification/validation investigations, and others).
• Leads, coaches, and develops direct reports to evaluate and execute continuous improvement, strengthen their skill sets, and foster an environment of continuous learning, improvement, and innovation.
• Establishes, monitors, and communicates team performance metrics, setting clear expectations and accountability for high performance.
• Oversees and drives staff scheduling to meet workflow demands and manages resources and expenditures to ensure alignment with budget expectations and prevent overruns.
• Drives and maintains harmonization of approach across program teams (analytical specifications, analytical method lifecycle).
• Represents and leads Quality Control engagement on various teams across Vericel by responding to new requests and integrating with SMEs across functional areas, including manufacturing operations, method lifecycle, process validation, material specifications, batch analysis, stability, and reference standards, and ensures alignment of information across stakeholders.
• Evaluates and communicates priorities, timelines, constraints, and opportunities, ensuring alignment across teams.
• Partners cross-functionally with Quality, Regulatory, Manufacturing, Process, and Analytical Development.
• Partners with Regulatory-CMC to author, coordinate, and update clinical and commercial filings (IND, IMPD, BLA, MAA) and supports responses to agency questions as needed.
• Leads and facilitates QC awareness of regulatory interactions, queries, commitments, and method introduction/change strategies.
• Ensures that all Quality Control activities are conducted in accordance with current Good Manufacturing Practices (cGMP) and other relevant regulatory requirements and drives adherence to safety procedures and guidelines.
• Authors and revises SOPs for managerial review and approval and creates new documentation where appropriate.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees