Manager, Operations (Collagen)

Getinge•Mahwah, NJ

31d•$138,000 - $145,000•Onsite

About The Position

The Manager, Collagen Operations serves as the sole site leader for the Mahwah, NJ Collagen facility and carries full responsibility for all site personnel decisions, site performance, and operational escalations. This role ensures the safe, compliant, and efficient operation of the site while driving a strong culture of quality, engagement, and continuous improvement. This position is accountable for the implementation of operational strategy as defined by the Getinge France (La Ciotat) leadership team. The Manager must ensure that all production activities adhere to U.S. regulatory protocols, including FDA, ISO, GMP, ESD, and Medical Device requirements, while also ensuring that all U.S. people practices (HR, safety, compliance, labor standards) are fully adopted and consistently upheld. The Manager leads the site in achieving production, safety, quality, and delivery objectives while ensuring strong communication, alignment, and reporting back to the Getinge France entity.

Requirements

High school diploma required; advanced education preferred.
3–5 years of experience as a production manager in medical device or similarly regulated environment.
Demonstrated ability to lead teams and run a manufacturing site with a high level of autonomy.
Strong computer skills; SAP experience a plus.

Nice To Haves

Experience in cleanroom or controlled environment operations preferred.
SAP experience a plus.

Responsibilities

Serve as the highest-ranking leader on-site, responsible for daily operational oversight.
Act as the primary escalation point for all personnel, safety, compliance, and operational matters.
Maintain a proactive presence on the production floor; ensure alignment between site activities and La Ciotat leadership direction.
Lead all site-level communication, engagement efforts, and leadership routines.
Serve as the site owner for safety, quality, and environmental compliance.
Ensure strict adherence to all U.S. regulatory requirements, including FDA, ISO, GMP, ESD, environmental, and medical device standards.
Ensure all U.S. people practices—including investigations, corrective action processes, documentation, training standards, and HR compliance—are consistently applied.
Guarantee timely and effective management of nonconformances, CAPAs, and deviations; lead site-level reviews and escalations.
Lead the execution of the annual production plan and ensure on-time delivery in alignment with customer needs and La Ciotat directives.
Oversee production scheduling, resource planning, inventory management, and staffing decisions.
Ensure production equipment, cleanroom environments, and facilities are properly maintained and audit-ready.
Manage manufacturing engineering and support functions to drive continuous improvement, cost savings, and process optimization.
Ensure documentation accuracy and compliance, including SOPs, controlled documents, training records, and batch documentation.
Full responsibility for all site personnel management, including hiring, onboarding, development, coaching, performance management, and employee relations.
Drive a culture of engagement, teamwork, and accountability consistent with Getinge values and U.S. people practices.
Set clear objectives, oversee workload planning, conduct performance reviews, and support career development.
Collaborate closely with the La Ciotat Production Director and France-based teams to ensure alignment on operational execution, reporting, and strategy.
Partner with U.S.-based HR, Quality, EHS, Engineering, and Supply Chain teams to ensure compliance and best practices across all site functions.
Coordinate validation, feasibility builds, technical projects, and operational readiness with sustaining engineering and global partners.
Organize and manage site production resources to meet daily, weekly, and annual plans.
Anticipate operational needs and align staffing with forecasts.
Define short-term production plans compatible with demand and capacity.
Lead investigations into deviations, failures, or operational issues and implement corrective actions.
Oversee preventive and corrective maintenance and technical shutdowns.
Submit and manage investment requests to support operational goals.
Ensure all personnel comply with safety rules, gowning, cleanroom regulations, and quality protocols.
Maintain readiness for internal and external audits at all times.