Senior Manager, Operations
Location:
Rochester, NY (Onsite)
Industry:
Regulated manufacturing (medical device / life sciences)
Travel:
Limited, as needed
Reports to:
Director of Manufacturing / Site Operations Leader
Compensation:
170K salary range + 20% bonus + benefits (commensurate with experience)
The Opportunity
A well-established manufacturer operating in a highly regulated environment is seeking a
Senior Manager, Operations
for the Rochester, NY facility.
This is a
high-visibility, senior leadership role
with responsibility for a
24x7 multi-shift operation
, focused on operational excellence, safety and environmental improvements, equipment performance optimization, and team development. The role plays a critical part in driving performance, reducing operational risk, and strengthening manufacturing systems and culture.
The ideal candidate is a
hands-on operations leader and change agent
with experience in high-volume manufacturing, strong people leadership capabilities, and a proven ability to improve OEE, quality, and engagement in regulated environments.
Why This Role Is Unique
-
Ownership of a
mission-critical, 24x7 manufacturing operation.
-
Opportunity to strengthen and evolve
tiered operating mechanisms and standard work.
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Strong mandate to improve
EHS, equipment effectiveness, and process capability.
-
High degree of influence across Manufacturing, Quality, R&D, Supply Chain, Finance, and Facilities.
-
Blend of
strategic leadership and hands-on operational execution.
Key Responsibilities
Operational Leadership
-
Lead daily operations to meet production, quality, cost, and safety objectives.
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Set operational goals, KPIs, and development paths for supervisors.
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Deploy, monitor, and sustain standard work across the operation.
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Lead a multi-shift supervisor team supporting a 24x7 manufacturing schedule
Process & Performance Optimization
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Drive continuous improvement initiatives to improve OEE, reduce downtime and waste, and optimize changeovers.
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Assess and improve operational practices to reduce errors and improve process capability.
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Apply formal problem-solving tools while addressing real-world equipment and process challenges.
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Make risk-based decisions to optimize equipment performance while maintaining product quality and employee safety.
Quality & Regulatory Compliance
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Proactively improve quality performance, reduce nonconformances, and drive CAPA implementation.
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Ensure compliance with cGMP, FDA, OSHA, ISO, and internal quality systems.
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Oversee manufacturing documentation, investigations, SOPs, batch records, and NCMRs.
Cross-Functional Collaboration
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Partner with R&D, Quality, Engineering, and Supply Chain on new product introductions, validations, and troubleshooting.
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Communicate capacity constraints, technical risks, and performance trends to Planning and Finance.
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Collaborate with Facilities on short- and long-term equipment and layout planning.
People & Culture
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Lead, mentor, and develop supervisors and operators.
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Foster a culture of accountability, safety, continuous improvement, and performance.
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Support individual development plans and career progression for salaried and hourly employees.
Must-Have Qualifications
-
Bachelor’s degree in a
scientific or engineering discipline
(preferred).
-
8+ years of manufacturing operations experience.
-
3+ years in a leadership or people management role.
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Experience leading
high-volume, equipment-intensive manufacturing operations.
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Strong knowledge of
GMP and regulated manufacturing environments.
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Experience with manufacturing documentation, investigations, and quality systems.
-
Proven ability to drive operational improvements tied to OEE, scrap, waste, and productivity.
-
Experience with Lean Manufacturing, Six Sigma, or similar methodologies.
Nice-to-Have / Preferred
-
Experience in
medical device, pharmaceutical, or similarly regulated industries.
-
Lean Six Sigma certification (Green Belt or higher).
-
Experience strengthening tiered accountability systems and standard work.
Precision Talent Partners, LLC values diversity and is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive workplace where all employees feel respected, supported, and empowered to contribute. This description reflects management’s assignment of essential functions and does not restrict the tasks that may be assigned. Employment is at-will, and this job description does not constitute a contract of employment.