Director, Quality Compliance

Cellares; Bridgewater (MA); On-site; USD 90,000 - 210,000; Full time

Benefits offered by this job

Highly subsidized Medical, Dental, and Vision Plans

401(k) Matching

Onsite lunches

Stock options

Job summary

Cellares in Bridgewater is seeking a Director, Quality Compliance to lead quality compliance activities. This role involves managing the Quality Compliance group and ensuring adherence to Cellares’ Quality Management System and regulatory standards.

The ideal candidate will have over 10 years of GMP experience in pharmaceuticals or gene therapy, along with strong leadership and regulatory knowledge. Compensation ranges from $90,000 to $210,000, with a comprehensive benefits package including subsidized medical plans and stock options.

Qualifications

• 10+ years of experience in a GMP environment in pharmaceutical, biologics, or gene therapy.
• 5+ years of leadership experience with demonstrated knowledge of cGMP regulations.
• Hands-on experience with GMP Quality Systems.

Responsibilities

• Manage and lead the Quality Compliance group.
• Ensure adherence to Cellares’ Quality System and regulatory standards.
• Collaborate on global Quality audits.

Skills

Experience in GMP environment

Leadership experience

Knowledge of quality systems

Understanding of regulatory compliance

Knowledge of cell and gene therapy regulations

Education

Bachelor’s degree or higher in a scientific or engineering discipline

Tools

Quality Management System

Job description

We are seeking an innovative and highly motivated Director, Quality Compliance to lead the quality compliance activities for the Bridgewater site. The role focuses on identifying and assessing regulatory and quality risks during site GMP operations and ensuring adherence to global regulations and Cellares’ policies and procedures.

This individual will manage continuous inspection readiness, the site’s self-inspection program, and routine use of the Cellares Quality Management System.

Candidates should thrive in a fast-paced, mission-driven environment and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

• Manage and lead the Quality Compliance group including quality systems, inspection management training, and operations regulatory compliance
• Ensure the implementation and maintenance of the Cellares Quality Management System at Bridgewater with the goal of maximizing efficiency, effectiveness and compliance with all applicable GMP regulations
• Direct the compliance programs for all cGMP areas and promote a strong Quality culture within the global organization, including a strong presence in Quality, Manufacturing, MSAT, Supply Chain and Purchasing, Analytical Development, Process Development, and Engineering
• Ensure adherence to Cellares’ Quality System, regulatory standards and Federal laws
• Support tech transfer of late stage/commercial cell therapy products and equipment coming through the organization pipeline
• Serve as key lead during team and other technical forums with respect to compliance and regulatory strategies
• Provide Quality direction and strategy for operational issues or technical challenges
• Manage and oversee the Document Management System & Data Integrity programs for paper and electronic based systems ensuring compliance with 21 CFR Part 11 regulatory standards
• Prepare and host periodic Quality Management Reviews to assess the effectiveness of the Quality Systems; identify unfavorable trends and collaborate with site stakeholders and functions to ensure their timely mitigation
• Evaluate, contribute, and approve change controls, risk assessments, quality events, CAPAs, and other investigations as they relate to compliance and technical challenges and implementation plans
• Contribute to CMC sections of regulatory filings, proprietary reagent filings, and other regulatory filings including client and business support paths
• Key lead during site preparation of regulatory and customer inspections including personnel preparation and training
• Collaborative host of regulatory and customer inspections and audits
• Preparation and approval of follow up activities including responses, commitments, CAPAs, and other strategy plans
• Manage and oversee the self inspection and internal audit programs
• Perform and collaborate on global Quality audits with respect to internal and external customers
• Responsible for the GMP Training program and ensuring its ongoing effectiveness and alignment with GMP job functions and job descriptions
• Review and approve SOPs, manufacturing batch records, specifications, validation protocols and reports, instrument acquisitions, impact, and decommissioning, work orders, and other Quality operations as needed
• Collaborate with functional area leads during planning and process/continuous improvement plans, projects, and gap assessments as they relate to proprietary instruments and manufacturing operations
• Oversee and monitor Quality metrics ensuring data is understandable and translatable to the appropriate audience(s)
• Mentor, coach, and manage staff performance and development

Requirements

• Bachelor’s degree or higher in a scientific or engineering discipline
• 10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
• 5+ years of leadership experience, and demonstrated knowledge of relevant cGMP regulations
• Excellent knowledge of the regulations for biologics, cell and gene therapy products
• Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is required
• Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
• Hands-on experience with designing and implementing GMP Quality Systems
• Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
• Demonstrated experience in preparing regulatory submissions and response to health authorities queries

Compensation

$90,000 - $210,000 a year. Cellares total compensation package includes competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.