Senior Director Analytical Development

Executive Director, Quality Control and Analytical Development

~ Burlington, MA ~

Local Candidates Only Please

The Executive Director is accountable for overseeing all aspects of Quality Control and Analytical Development within the organization including QC systems, Analytical Chemistry, Microbiology (including Environmental Monitoring), Method Validation and Product Stability ensuring that the company QC practices comply with relevant industry standards, governmental regulations, and certifications. The Executive Director directs the development, planning, implementation, and is accountable for the Quality control methods, processes, and operations for all company development and commercial products and/or technologies. The Executive Director provides strategic and tactical leadership to the Quality Control and Analytical organization is accountable for the execution of Quality control and analytical development responsibilities within the Quality System. This position directly manages the QC teams and is accountable for all work completed within the QC group for pharmaceutical and medical device products across the entire product lifecycle.

KEY RESPONSIBILITIES

• Leadership & Strategy: Accountable for the development and execution of the overall QC strategy in alignment with organizational goals. Lead the quality control teams in setting and achieving quality objectives. Direct the development, validation, planning, implementation, and maintenance of QC test methods, processes and operations applicable to the lifecycle stage of the product. Provide leadership for the Quality Control function through development and implementation of the overall quality strategic plan.
• Provide visionary leadership and strategic direction to a team of approximately 23 full-time quality professionals. This key executive will be responsible for shaping the quality culture across the organization, ensuring compliance with regulatory standards, and driving continuous improvement in quality systems and processes.
• Develop and execute a comprehensive quality strategy aligned with the company's business objectives and regulatory requirements for ophthalmic combination drug products
• Lead, mentor, and develop a high-performing quality team, fostering a culture of excellence, innovation, and continuous improvement
• Collaborate with cross-functional leadership to integrate quality considerations into all aspects of product development, manufacturing, and commercialization
• Serve as the primary liaison with regulatory agencies on quality matters, representing the company in inspections and audits
• Establish key performance indicators (KPIs) to measure and enhance the effectiveness of quality systems and team performance
• Oversee the development and implementation of quality policies, procedures, and training programs to ensure GMP compliance and product quality
• Provide executive-level guidance on quality risk management, change control, and CAPA processes
• Manage the department budget, resource allocation, and strategic hiring decisions
• Participate in due diligence activities for potential partnerships, acquisitions, or expansion opportunities, assessing quality implications and integration challenges
• Quality Control: Accountable for the direct oversight of the design, implementation, and maintenance of quality control processes, including testing protocols and inspection procedures, to ensure that all materials, components, and products meet or exceed applicable regulatory standards. Accountable for the development and validation of test methods in accordance with international guidelines. Accountable for ensuring that raw material, in-process and final release testing is accurate and reported to meet timelines. Accountable for ensuring the appropriate stability programs are initiated and completed to support both clinical and commercial products. Accountable for the design and execution of the site environmental monitoring program. Accountable for designing and implementing sterility and biological test/validation requirements utilizing appropriate current regulatory and industry standards for new products. Ensure projects are provided the suitable QC resource to meet common goals and timelines.
• Regulatory Compliance: Accountable for ensuring that the company QC practices comply with relevant industry standards, governmental regulations, and certifications. Maintain up-to-date knowledge of regulatory requirements and is accountable for the organization’s adherence to these standards. Accountable for ensuring GCLP principles are implemented and adhered to within internal and external third-party laboratories. Manages internal and external CGMP laboratories by reviewing and approving documents as required, including SOPs, protocols, reports, test methods, change requests, technical transfers, OOS investigations. Accountable for ensuring that quality control systems and equipment are compliant to all applicable regulatory guidelines and data integrity principles are adhered to, to provide confidence in the data generated. Tracks and trends cGMP data including the evaluation and approval of data received from external third-party contract laboratories. Accountable for compliance with current regulatory requirements for the retain sample management program.
• Audit & Surveillance: Lead quality control investigations as needed for all development and commercial products. Accountable for the timely completion of corrective and preventative actions to ensure GxP compliance. Establish and oversee internal and external audit and surveillance programs to monitor compliance with quality standards. Lead efforts to address any identified gaps or areas of non-compliance and the timely completion of corrective and preventative actions to ensure GxP compliance. Develop, refine, and document quality control test and inspection procedures.
• Continuous Improvement: Drive continuous improvement initiatives within the QC functions. Analyze quality data and performance metrics to identify trends and opportunities for process enhancement. Ensures continuous improvement across the Quality Control Group.
• Training & Development: Develop and implement training programs, standards, tools, and methods to enhance the skills and knowledge of the QC teams and promote a culture of quality throughout the organization. Oversee development of personnel within the quality department; direct training programs and prepare employee development plans and provide regular performance reviews.
• Collaboration & Communication: Accountable for the timely escalation of significant issues to Global Head of Quality. Communicates effectively with top management, providing regular updates on QC performance and issues. Coordinates closely with Quality Assurance on all QC related issues and ensures Quality Agreements are complete, approved and updated at appropriate intervals. Ensure contract laboratory service providers are suitably qualified to conduct the services contracted to them. Work closely with other departments, including Regulatory Affairs, production, engineering, and supply chain, to ensure that quality considerations are integrated into all aspects of the business. Interface with R&D, CMC and Regulatory Affairs to ensure that all material specifications are suitable for their intended purpose. Compiles and reports data with appropriate interpretations for internal Management Reviews, Annual Product Reviews, and all other required assessments.
• Manage Quality Control and Analytical development teams

KEY REQUIREMENTS

• Must have a minimum of 15 years of experience in a pharmaceutical quality control role (CMC, Phase 1-3 clinical development); 5 years in a management position.
• Experience in the management of QC Systems, Quality Analytical Chemistry, Stability, Analytical Validation, Microbiology.
• Must be knowledgeable in the application of quality principals and industry guidelines for Quality Systems.
• At least 5 years of experience in a senior management / leadership capacity
• Demonstrated knowledge and experience in analytical development.
• Must be able to advise and/or teach others on the quality requirements of the company, including products, customer requirements and the interpretation of various industry guidelines.
• Must have experience in risk-based decision making.
• Demonstrated operational excellence of laboratories.
• Must have strong hands-on leadership and communication skills.
• Must be able to conduct an audit; must be able to be audited. Must be familiar with statistical principals as they relate to statistical sampling plans.
• Minimal travel: however, may involve occasional travel to various production sites and partner locations to oversee quality processes and audits.
• Ability to gown and gain entry to manufacturing areas.
• Able to operate in a fast-paced environment, requiring a high degree of attention to detail and the ability to manage multiple priorities.

EDUCATION

• BS degree in a scientific/engineering discipline required; advanced degree in analytical development preferred.