Product Lifecycle Lead Operations

Gerresheimer•Peachtree City, GA

2d•Onsite

About The Position

The Product Lifecycle Lead Operations will serve as the main contact and coordinator for the customer and the internal voice of the customer regarding technical, organizational, or general topics during series production. This role is crucial during the transfer phase (Phase IV/V) and process qualification/validation, including the execution of projects according to the stage-gate process. The position also involves supporting global functions during project realization phases (Phase I-III) and acting as a coordinator within the Customer Facing Team. The role requires managing cross-functional teams with experts in areas such as Process Engineering (Injection Molding/Assembly), Tooling, Quality, Service, and Order Management, in coordination with managers, to address daily business, customer complaints, and escalations. This position is the main reporting person to internal and external stakeholders for strategic business reviews, reporting, and steering meetings. The role involves organizing customer meetings and visits, representing corporate and customer interests while considering corporate strategy, and coordinating/driving internal work packages like Equipment Validations, Kepner Tregoe & Six Sigma Projects, and documentation reviews. It requires targeted and trustful cooperation with internal and external interfaces, including production areas, technical services, customer service, plant management, OPEX, TCC/SEC, and the customer. Participation in customer audits, responsible processing of change requests, and implementation of new projects/capacity expansions are also key responsibilities. The role holder will assume the PLP role, coordinating all task packages affecting the production plant, and independently ensuring compliance with standards, legal provisions (e.g., working hours law, occupational safety regulations), and internal regulations (SOPs, BVs, etc.).

Requirements

Knowledge obtained by technical or scientific study or equivalent technical education (e.g., mechanical technician, injection molding technician) with professional experience in the medical/pharmaceutical industry.
Solid professional experience in the field of Quality for at least 5 years.

Responsibilities

Serve as the main contact and coordinator to the customer and internal voice of the customer for technical, organizational, or general topics during series production (excluding Supply Chain & Quality Topics) for a specific customer or product portfolio over the entire product lifecycle.
Execute projects according to the stage-gate process during the transfer phase (Phase IV/V) and process qualification/validation.
Support global functions during project realization phases (Phase I-III).
Act as a coordinator within the Customer Facing Team.
Manage cross-functional teams with experts (Process Engineers Injection Molding/Assembly, Tooling Engineer, Quality, Service Team, Order management, etc.) in coordination with managers, for daily business, customer complaints, and escalations.
Serve as the main reporting person to internal and external stakeholders (e.g., Strategic Business Review, Reporting, Steering Meetings).
Organize customer meetings and visits.
Represent corporate and customer interests, taking corporate strategy into account.
Coordinate and drive internal work packages (e.g., Equipment Validations, Kepner Tregoe & Six Sigma Projects, Review of Documentation, Changes).
Engage in targeted and trustful cooperation with internal and external interfaces (e.g., production areas, TS, CS, plant management, OPEX, TCC / SEC and especially the customer).
Participate in customer audits.
Process change requests responsibly.
Implement new projects / capacity expansion in the plant, assuming the PLP role (coordination of all task packages that affect the production plant).
Independently comply with standards, legal provisions (e.g., working hours law, occupational safety regulations), and internal regulations (SOPs, BVs, etc.).