Beschreibung
Randstad Professionals is actively looking for a Site Manager for our clients External Manufacturing, Combination Products and Devices. Within this External Manufacturing they provide strategic, outsourced manufacturing solutions, delivering high quality medicines to patients by providing network flexibility, broadening technical capabilities, and minimizing risk. The purpose of the offered job is to establish the strategy and lead the selection, implementation and management of clinical and commercial contract manufacturing organizations (CMO's).
Location: Basel
Tasks:
The job holder is accountable for the performance of the CMO to meet development, quality and supply requirements. Key focus of this role is devices & drug delivery systems (eg patch pumps, injection devices, auto-injectors, safety devices).
Manage complex development, supply and business relationships with CMOs in clinical and commercial phases in a structured governance environment.
Lead and collaborate with broad cross-functional internal and external teams (quality, supply chain, development, commercial, legal, finance ) to achieve the company`s business, development, manufacturing, technical and quality performance goals for the contract manufacturing relationships.
Collaborate on forecasting, production planning and perform required business process operations.
Collaborate with External Quality on quality system and compliance activities at CMOs/Partners.
Qualifications:
Must have
BA or Master Degree in Mechanical Engineering or equivalent required.
7-10 years of relevant experience in the medical devices or related industry required.
Demonstrated ability to effectively lead and work in large, cross-functional, cross-enterprise and multi-cultural project teams with subject matter experts of quality, manufacturing operations, supply chain management, processes engineering, product development, commercial, legal, finance,
Quality orientation with solid knowledge of GMPs, FDA regulatory guidelines and validation practices.
Demonstrated project management skills
International and domestic travel estimated at max 10%.
Nice to have
Operational experience in clean molding and assembly of plastic medical devices as well as experience in drug delivery device development. Experience in prefilled syringe filling preferred.
Strong ability to lead strategic outsourcing, business, operations and quality decisions at all levels of an organization, including ability to negotiate and develop contracts with minimal guidance
Demonstrated knowledge in financial concepts and cost-benefit analysis
Solid analytical and creative problem solving skills
Strong leadership skills and capable to effectively communicate at all levels
Core competencies
Communication, teamwork and collaboration
Decision-making & Result orientation
Technical expertise
Commercial/business sense
Languages
Fluent in English (must)
German (highly preferred as it is easing the interaction with the local assembly sites)