Summary of Objective:The Senior Manager of Operations Support reports directly to the Senior Director of Operations and is responsible for overseeing technical writing, investigations, finite scheduling, and project management across multiple PCI manufacturing sites within the Bedford campus. This role serves as a key leader on the Operations Leadership Team. The role is critical to ensure ongoing GMP compliance and adherence to quality standards across all department staff and processes.
Essential Duties and 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.
- 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.
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