Senior Manager, Operations Support

About the role

We are PCI. Our investment is in People who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Responsibilities

• Provide technical leadership and strategic oversight for the Operations Support group across multiple PCI Manufacturing sites at the Bedford campus.
• Build and lead a team of process specialists who will work closely together and within a highly matrixed, cross-functional team to successfully deliver business objectives.
• Develop and manage Manufacturing and Visual Inspection (VI) finite schedules to align with customer demands and PCI objectives.
• Plan and prioritize technical writing projects, including: investigations, Quality Systems (Change Controls, CAPAs, etc), Standard Operating Procedures (SOPs), and other documentation, in collaboration with cross-functional teams.
• Lead a team that oversees investigations to drive resolution of deviations, ensuring effective root cause analysis and corrective actions.
• Establish, analyze, and maintain key performance metrics, including: safety, quality, on-time/right-first-time delivery, inventory, and productivity.
• Develop and implement strategies for continuous improvement across manufacturing processes that reduce cost, save time, improve process attributes, and optimize quality.
• Interpret manufacturing process data, identify trends, troubleshoot problems, and drive data-driven decision-making with effective and concise communications.
• Serve as a department Subject Matter Expert (SME) during customer and regulatory audits.
• Interface directly with all clients to ensure the highest level of customer satisfaction is achieved.
• Act as a highly visible, hands-on leader, responsible for coaching, mentoring, and developing high-performing teams while fostering a culture of accountability and excellence.
• Oversee the professional development of the Operations Support team, conducting individual performance reviews, setting goals, and driving employee growth.

Special Demands

• Ability to stand, sit or remain in the same position for extended periods of time.
• May be required to travel between sites at the campus.
• Follow written instructions.
• Able to train others.
• Able to work in a highly complex environment with competing demands and priorities.

Work Environment

• Primarily interacts with staff in the following departments at all levels: Operations, Quality, Project Management, Engineering, Supply Chain, and MSAT.
• Will frequently interact with clients and client representatives.
• Will frequently interact with external vendors.
• Manage 4-5 Direct reports, supporting a team of 10-15 Indirect Reports.
• Travel to various PCI locations up to 15% annually.

Qualifications

• Minimum of 8 years of technical experience with Life Sciences (Biopharmaceutical / Biotechnology) and/or Medical Device with GMP industry experience.
• BS/MS in chemical, mechanical, pharmaceutical engineering or relevant work experience. Comparable blends of education and experience is acceptable.
• Strong hands-on experience in either Process Engineering/Sciences, Manufacturing Operations, Technical Project Management, and/or Quality.
• Experience preferably in a biopharmaceutical or medical device manufacturing organization with familiarity with aseptic manufacturing a plus.
• Prior people managing experience, supervisory experience at a minimum.
• Experience leading and driving large projects and initiatives to completion.
• Positive attitude with strong interpersonal skills.
• Proven leadership, persuasiveness, initiative, and problem-solving abilities.
• Strong communication skills, both verbal and written.
• Able to inspire and motivate.
• Self-motivated with a drive for excellence.
• Resilient through operational and organizational change.
• Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs.