Regulatory & Quality (Life Sciences)·Posted on Nov 12·
Full-timeNeedham, MA, USA$184k - $200k /yr
About the Job
Requirements
A Bachelor's degree or equivalent in Chemistry, Microbiology, or Biological Sciences and at least 8 years of experience in the cGMP pharmaceutical or biotech industry, or a Master's degree or equivalent in Chemistry, Microbiology, or Biological Sciences and at least 6 years of experience in the cGMP pharmaceutical or biotech industry.
Experience supporting biologics, viral vector, or advanced therapy products.
Familiarity with test methods for evaluating diverse samples, including cell banks, in-process samples, drug substance, and drug product.
Strong knowledge of QC systems, including validation, microbiology, stability, and data integrity.
Knowledge of USP, EP, and JP monographs.
Knowledge of cGMP, ICH, FDA, and EU regulations.
Familiarity with cGMP systems such as TrackWise, Veeva, and LIMS.
Ability to work independently or with minimal supervision and flexibility to manage workflow in a multitasking environment.
Applicants must be authorized to work in the United States and must not require sponsorship.
Responsibilities
Manage routine testing of in-process, final product, and stability study samples according to Standard Operating Procedures and approved methods.
Coordinate with Research and Analytical Development to transfer qualified or validated methods into QC or to and from external laboratories.
Ensure internal QC laboratories and operations comply with GxP requirements, including analytical equipment qualification, sample management, maintenance, and calibration programs.
Oversee internal and external laboratory operations, including CTLs and CDMOs.
Ensure QC procedures, practices, and methods comply with applicable compendial, regulatory, customer, and internal SOP requirements.
Lead and manage QC investigations, including OOT and OOS investigations, change controls, and CAPAs, and ensure investigations are thorough.
Ensure data integrity principles are understood and consistently implemented in QC laboratories and operations.
Establish and report applicable department or organizational metrics.
Support regulatory submissions and inspections in collaboration with QA and Regulatory Affairs.
Advance QC through digital transformation, automation, and laboratory systems, including LIMS and ELN.
Drive new technology, best practices, and qualification initiatives in QC.
Develop QC systems cross-functionally to meet US and global regulatory standards for commercial and clinical products and prepare the laboratory for pre-approval inspection and commercial launch.
Participate in preparing for regulatory inspections and facility audits.
Develop and issue trend reports.
Author, revise, and approve SOPs to improve efficiency and regulatory compliance.
Represent the QC department in project team meetings.
Perform management duties in accordance with company policies and practices.
Direct staff to ensure timely and accurate project execution in compliance with safety, budget, cGMP, and other applicable regulatory standards.
Select, develop, motivate, and challenge qualified staff to support high performance, department functions, and continuity of managerial and specialized skills.
Coach and mentor staff in job performance and career development, including training, feedback, and disciplinary action.
Develop work plans and project plans, assign tasks, and supervise teams.
Ensure staff have appropriate knowledge of department processes and procedures.
Desired Qualifications
Experience with advanced therapy modalities, including gene therapy and viral vectors.
Experience implementing digital QC systems.
Experience managing external laboratory networks.
Associate Director, Quality Control Salary: $184K - $200K Hybrid- Needham, MA office 2-3 days a week (We will not consider candidates who are not local)
Why Work With Us? Candel is a clinical-stage biopharmaceutical company developing innovative multimodal viral immunotherapies designed to harness the power of the immune system against cancer. With positive Phase 3 results from our lead program and BLA readiness underway, Candel is reaching an important inflection point—one that creates the opportunity to translate scientific innovation into meaningful impact for patients, while the company continues to advance the next generation of programs across solid tumors.
Position Summary
The Associate Director of Quality Control (QC) is responsible for managing routine testing of in-process, final product, and stability samples for both clinical and commercial products in accordance with Standard Operating Procedures and approved methods. The Associate Director of QC is also responsible for QC activities such as oversight of external testing laboratories, oversight of method validations and transfers, review of protocols and procedures, issuance of certificates of testing, providing data for annual product reviews, execution of the reference standard and critical reagents program, and providing data for QMR sections. This role serves as a key member of the Quality leadership team, ensuring that QC strategy, laboratory operations, and data integrity systems align with regulatory requirements, product quality objectives, and commercial readiness.
Key Interfaces
This role will work closely with Analytical Development, Process Development, Manufacturing, Quality Assurance, Supply Chain, Program Management, and external laboratories (CTLs/CDMOs).
Staff Management
Execute management duties in accordance with company policies and practices.
Direct staff to ensure timely and accurate execution of projects in full compliance with safety, budget, cGMP and other regulatory standards as required.
Select, develop, motivate and challenge qualified staff to drive high performance and effectively carry out department functions and provide for the continuity of managerial and specialized skills.
Coach and mentor staff in all aspects of their job performance and career development including training, feedback, and disciplinary action.
Develop work plans and appropriate project plans, assign tasks, and supervise team(s).
Ensure staff has appropriate knowledge of department processes and procedures.
Key Responsibilities
Oversee and manage routine testing of in-process, final product and stability study samples in accordance with Standard Operating Procedures and approved methods.
Coordinate with the Research and Analytical Development departments to transfer qualified/validated methods into QC or to/from external laboratories.
Ensure internal QC laboratories and operations operate according to GxP’s. This includes but is not limited to analytical equipment qualification, sample management, maintenance, and calibration programs.
Oversee internal and external laboratory operations, including CTLs and CDMOs.
Ensure that QC procedures, practices and methods are in compliance with the applicable compendial, regulatory (FDA, EMA, ICH) and customer requirements as well as internal SOPs.
Responsible for Quality System records associated with Quality Control testing including but not limited to leading and managing QC investigations (OOT/OOS), change controls, CAPAs, and ensure investigations are thoroughly conducted.
Ensure that data integrity principles are understood and implemented consistently in the QC laboratories and operations.
Establish and report applicable department or organizational metrics.
Support regulatory submissions and inspections in collaboration with QA and Regulatory Affairs.
Advance QC through digital transformation, automation, and laboratory systems (LIMS, ELN).
Drive new technology, best practice, and qualification initiatives in QC.
Work cross-functionally to develop QC systems that meet the standards expected by US and global regulatory authorities in support of commercial & clinical stage products and prepare the laboratory for pre-approval inspection for commercial launch.
Participate in preparation of regulatory inspections and facility audits.
Develop and issue trend reports.
Author, revise, and approve SOPs to improve efficiency and regulatory compliance.
Represent the QC department in project team meetings.
Required Qualifications
Bachelor’s degree or equivalent in Chemistry, Microbiology or Biological Sciences and 8+ years of experience in a cGMP pharmaceuticals or biotech industry or Master’s degree or equivalent in Chemistry, Microbiology, or Biological Sciences and 6+ years of experience in a cGMP pharmaceutical or biotech industry.
Experience supporting biologics, viral vector, or advanced therapy products.
Familiarity with a wide range of test methods needed for evaluation of diverse samples, such as cell banks, in-process, drug substance and drug product.
Strong knowledge of QC systems including validation, microbiology, stability, and data integrity.
Demonstrate knowledge of USP, EP, JP monographs
Demonstrate knowledge of cGMP/ICH/FDA/EU regulations
Familiarity with cGMP systems (e.g. TrackWise, Veeva, LIMS, etc.).
Ability to work independently, or under minimal supervision, and with flexibility to handle workflow in a multi-tasking environment.
Preferred Qualifications
Experience with advanced therapy modalities (gene therapy, viral vectors).
Experience implementing digital QC systems.
Experience managing external laboratory networks.
Leadership Competencies
Strategic leadership with strong quality expertise.
Ability to influence cross-functional teams.
Commitment to quality culture and inspection readiness.
Excellent communication skills.
NOTE: All applicants must be authorized to work in the US and do not require sponsorship. Unfortunately, we are unable to provide sponsorship of any kind at this time.