Associate Director, Quality Control Technical Services

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine.

Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary

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.

Schedule:

This position is onsite Monday - Friday in our new Burlington, MA office, but will be required to spend some days in our Cambridge office as we transition to our new facility. This role requires flexibility for shifts, weekends, and holidays, as well as the ability to provide coverage during inclemet weather.

Key Responsibilities:

Quality Control Technical Services & Method Lifecycle

* 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).

Analytical Strategy, Cross-Functional Leadership & Team Management

* 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.

Regulatory Compliance & Quality Systems

* 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…