We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. We offer a strong benefits package, opportunities for growth, and the chance to contribute to our mission: to provide an integrated portfolio of healing solutions that improve lives while lowering the overall cost of health care.

The Facilities Compliance Manager is responsible for leading the Facilities Compliance Group containing CMMS Specialists and Quality Compliance Specialists. The Facilities Compliance group will be responsible for Blue Mountain Ram operations, deviation investigations and closure, leading CAPA investigations and GMP cleaning. The Facilities Compliance Manager will also be the lead liaison between facilities and the quality assurance department.

Key Responsibilities

• Responsible for compliant operation the CMMS system which is used to track preventative maintenance, corrective maintenance, calibrations and validations.
• Ensure on a monthly basis all preventative maintenance and calibrations are performed on time. Develop reports so other Facilities Managers can ensure PM’s, GWR’s and projects are completed on time.
• Ensure new equipment is properly added to CMMS to meet change control guidelines.
• Oversees Facilities cleaning program
• Reviews and approves facilities work orders for completeness and accuracy
• Works as the facilities liaison for Equipment Change Controls related to the CMMS
• Leads a team of compliance specialists tasked with Deviation Closure, CAPA investigations and GMP Investigations
• Works with Facilities Manager to ensure facilities training program is operated in a compliant manner
• Ensures their work meets QA compliance requirements, that all tasks are completed on schedule and problems resolved in an efficient and effective manner.
• Responsible for special projects as directed by supervisor
• Performs all other duties as assigned.

Preferred Education and Experience

• Bachelor of Science degree preferred plus at least 10 years of relevant experience
• Previous experience in cGMP Manufacturing, Quality Control and Facilities Management required
• Previous experience with leading CAPA teams required
• Previous experience with SOP drafting required
• Previous experience with Deviation investigations required
• Previous experience with CMMS systems required

Other Skills and Abilities

• Ability to work with other Facilities groups and other departments to problem solve issues. Strong collaboration abilities.
• Self-starter who can perform tasks with minimal supervision
• Computer literate with Microsoft products such as Excel, Word Power Point
• Problem solving skills
• Ability to work cross functionally across all Organogenesis departments.