Sr Manager, Operations

PCI Pharma Services; Bedford (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

PCI Pharma Services in Bedford is seeking a Senior Manager of Operations Support to oversee technical writing, investigations, finite scheduling, and project management across multiple PCI Bedford sites. This role leads the Operations Leadership Team to ensure GMP compliance and adherence to quality across staff and processes.

The role requires 8+ years in Life Sciences GMP, engineering degree, and proven leadership of large projects and cross-functional teams. Travel up to 15% is expected.

Qualifications

• 8+ years of technical experience in Life Sciences GMP or Medical Device environments.
• BS/MS in chemical, mechanical, pharmaceutical engineering or related field.
• Strong hands-on experience in Process Engineering, Manufacturing Operations, Tech Project Management, or Quality.
• Experience leading and managing teams and large projects.
• Excellent written and verbal communication; ability to interact with customers/regulators.

Responsibilities

• Provide technical leadership for Operations Support across PCI Bedford sites.
• Build and lead a matrixed team of process specialists to deliver objectives.
• Develop and manage manufacturing and VI finite schedules aligned with customer demands.
• Plan technical writing projects, investigations, QA systems (Change Controls, CAPAs, SOPs).
• Lead investigations to drive root cause analysis and corrective actions.
• Maintain KPIs for safety, quality, on-time delivery, inventory, and productivity.
• Drive continuous improvement to reduce cost and improve process attributes.

Job description

Overview

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

Organization

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.

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.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.