Associate Director, MFG Training, Compliance and OpEx

About the role

The Associate Director, MFG Training, Compliance and OpEx will report to the VP Manufacturing and Operational Excellence and will lead the strategic design, implementation, and continuous improvement of manufacturing training programs, regulatory compliance frameworks, and Operational Excellence (Opex) initiatives. This role ensures the production workforce is highly skilled, fully compliant with international regulatory standards (e.g., FDA, EMA, ISO), and equipped to drive efficiency through Lean and Six Sigma methodologies.

Responsibilities

• Regulatory Compliance & Quality Assurance
  • Audit Readiness: Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are defined and completed. Serve as a primary subject matter expert (SME) during internal and external regulatory inspections.
  • Quality Systems Management: Lead investigations into manufacturing deviations, establish Corrective and Preventive Actions (CAPAs), and ensure timely closure. Support cross-functional teams in risk analysis associated with Change Controls, complaint investigation, failure investigation (FMEA) and hazard assessments (HACCP).
  • Documentation Control: Oversee the creation, review, and optimization of Standard Operating Procedures (SOPs) and Batch Records to eliminate compliance gaps.
• Workforce Training & Competency Development
  • Program Architecture: Design and deploy site-wide technical training curricula, onboarding programs, and annual refresher courses.
  • Matrix Tracking: Maintain the electronic Learning Management System (eLMS) to track qualification matrices, ensuring 100% training compliance before tasks are executed.
  • Instructional Delivery: Partner with operations management to implement On-the-Job Training (OJT) and trainer-certification protocols.
• Operational Excellence (Opex) & Continuous Improvement
  • Lean Culture: Cultivate a site-wide culture of continuous improvement using Lean, 5S, Kaizen, and Value Stream Mapping (VSM).
  • Waste Reduction: Identify bottlenecks in the production cycle to reduce scrap rates, optimize cycle times, and lower manufacturing costs.
  • Key Metrics: Establish and monitor Departmental KPIs, including First Time Right (FTR), training compliance rates, and Opex savings.
• Leadership & People Management
  • Team Development: Mentor and manage a team of training specialists, compliance coordinators, and continuous improvement engineers and drive cross site alignment and consistency.
  • Cross-Functional Collaboration: Partner with Quality Assurance, Engineering, and Supply Chain leaders to align site goals.

Required Skills & Knowledge

• Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
• Ability to translate complex regulatory requirements and data trends into simple, actionable manufacturing workflows
• Experience with inspection readiness initiatives and in involvement with PAI inspections
• Exceptional verbal and written communication skills to influence cross-functional stakeholders and present data to executive leadership
• Proven track record of systematically resolving root causes of operational and compliance issues
• Ability to work collaboratively in a fast-paced, dynamic work environment, while managing multiple priorities
• Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment are essential
• Flexible and able to respond quickly to shifting priorities and meet deadlines
• Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment

Qualifications

• Education: Bachelor's degree required in Engineering, Life Sciences, Business Operations, or a related technical field. Master's degree or MBA is a plus.
• Experience: Minimum of 10 years of related experience in the pharmaceutical, biotechnology or Medical Device industry, with at least 5 years in a leadership or supervisory role.
• Six Sigma Green Belt or Black Belt certification is highly preferred. Lean Master or PMP certification is a strong asset.
• Demonstrated management skills, including leadership, talent assessment, recruitment, employee retention and development

Pay

Target salary range: $150,380 - $190,207 USD

Schedule

Hybrid role supporting our Northbridge and Watertown facilities. Travel to MFG locations is required to support a multi-site team three days in-office but could be more at times as we approach upcoming critical milestones. May travel to external partner locations (5-10%).