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Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
The Quality Compliance Manager, ECMP Site Facilitator, provides tactical support and oversight of the implementation of the Enterprise Compliance Master Plan at Integra LifeSciences sites. They are responsible for to developing individual site project plans derived directly from the Enterprise Compliance Master Plan (ECMP), and ensuring that the project plans are being implemented according to the defined timeline and plan. Site Facilitators will work closely with existing site Quality and Operations leaders and may have responsibility for more than one site.
The QC Manager, Site Facilitator will report to the main Site Location: Le Locle, CH and will be required to travel to other sites when needed: St. Aubin, FR, Tullamar, IE, and Rietheim-Weilheim, DE
Key Responsibilities
- Developing and managing sites’ project plans for implementation of ECMP workstream outputs;
- Tracking progress and ensuring execution according to plan;
- Reporting sites’ progress to ECMP Program Management Office (PMO);
- Being responsible for ECMP documentation and schedule at sites;
- Coordinating collaborative activities between sites’ local activities;
- Periodically reviewing the outputs from the sites’ work stream activities to ensure it is aligned with requirements of the ECMP and individual site’s project plan;
- Facilitating resolution to issues
- Other duties as assigned.
Requirements
- Bachelor's degree is required, (Engineering, Science or closely related technical discipline is preferred)
- 10+ years of experience leading a team (indirect reports and/or projects) or equivalent education and years of management experience.
- Experience working Quality Management Systems and understanding compliance.
- Experience in highly regulated industries required, medical device and/or pharmaceutical preferred, including material remediation experience.
- Experience in implementing remediation programs, and working with compliance frameworks such as FDA, ISO 13485, and EU MDR.
- Demonstrated management and communication skills. Proven track record of cross-functional collaboration across teams and change management skills.
- Strong attention to detail skills
- Strong communication and presentation skills, with the ability to articulate program status and risks to key stakeholders.
- Ability to travel up to 50% if needed based on site needs. Regular on-site presence at designated facilities within scope of responsibilities.
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, smart phone as well as other general office equipment. Strong computer skills are required.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
ADVERSE WORKING CONDITIONS
There are no adverse working conditions associated with this position.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.