Director, Quality Operations

Job Summary

The Director of Quality Operations is responsible for providing quality oversight to all manufacturing operations in support of clinical development and commercial products, including but not limited to, Drug substance, Process Intermediates, and Drug Product(s). This role requires extensive interaction with Clinical Operations, Pharmaceutical Operations, Program and CMC project management, Regulatory Affairs, Supply Chain, and CMOs, to achieve sustainable compliance in GxP operations.

Responsibilities

• Provide quality oversight to all manufacturing operations in support of clinical development and commercial products.
• Ensure all manufacturing activities in support of Drug substance, Process Intermediates, and Drug Product(s) are conducted in accordance with internal company standards and in compliance with quality agreements.
• Formulate and administer policies and standard operating procedures (SOPs) relating to the Quality Operations function and quality management system, identifying opportunities for improvements.
• Own real time batch record review and resolution of associated deviations prior to product disposition.
• Provide quality oversight of Deviations, Change Controls, CAPAs, etc., including those at the CMO sites.
• Develop and implement appropriate quality training for the team.
• Assure availability of all required documentation and support for the Annual Product Reviews.
• Review CMC sections for regulatory submissions to ensure accuracy and completeness.
• Participate in activities to assist with regulatory submissions, control strategy development and CMC strategy.
• Provide quality review and approval of Technology transfer protocols and final reports.
• Prepare for regulatory inspections at the CMO sites.
• Define, develop, and implement short-term and long-term strategies, goals, objectives, and tactics relating to the Quality Operations function and the quality management system.
• Review and recommend appropriate corrective action to ensure consistency with the Quality Operations function and the quality management system.
• Use incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues.
• Represent Quality Operations function and quality management system and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities, and assist with quality-related information related to client assessments, RFPs, contracts, and other documentation.
• Assist Keros Quality Systems & Compliance team to perform GMP audits for vendors; follow through remediation plans assigned from audit observations and ensure internal and external CAPAs are completed within the mandated timelines.
• Maintain current knowledge base of regulations, corporate policies, and standards to ensure that the Quality Operations function remains in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.
• Support strategic planning by timely communicating Quality deliverables, constraints, risks, and options, and collaborating with Technical Development, Program management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.
• Identify risks and assumptions in plans, anticipate problems and plan for contingencies.
• Remove obstacles to move work forward and/or to get efforts back on track.
• Work effectively in team to help issue resolution.
• Provide phase specific guidance from quality perspective, and prioritize and multitask as necessary.
• Manage and mentor Quality operations staff to emphasize positional responsibilities, and personnel development.
• Coach and mentor quality personnel in necessary skills to review and approve highly technical documentation.
• Any additional duties assigned by supervisor.

Basic Qualifications

• Bachelor's Degree is required (Biological sciences, Engineering, or related degree); advanced degree is a plus.
• Minimum of 12 years CGMP Quality experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.
• Ideally a minimum of 8 years of experience in leading a Quality function.
• Ideally a minimum of 3 years of experience at the Director level with successfully managing direct reports.
• Strong knowledge of biological manufacturing process and testing.

Preferred Qualifications

• Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders.
• Leadership and management skills to grow and manage a high performing Quality organization.
• Demonstrated skills in project management and working with vendors and contractors.
• Strong understanding of FDA, ISO, EMA, GMP and ICH requirements ideally for ATMPs.
• Proven experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, excellent interpersonal skills, organizational skills, written and oral communication skills.
• Experience developing and executing organizational change, including change management strategy and planning.
• Energetic, flexible, collaborative, and proactive; a leader who can positively and productively impact initiatives.
• Available to work in the evenings and weekends if required.
• Ability to travel up to 30%.