Quality & Compliance Manager- Pharmaceutical Facilities Management- Durham, NC

CBRE

3.2

(31)

Multiple Locations

Why you should apply for a job to CBRE:

  • 65% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.

    #175314

    Position summary

    sures the integration and ongoing oversight aspects required by that QMS are appropriately performed by the CBRE Quality Representatives.

    This position collaborates with the client's Quality Assurance team leadership to support routine quality assurance and quality results. This position supports change, event & root cause analysis processes through review and/or approval actions. This role ensures all CBRE employees are qualified for the work they are performing.

    Lastly, this position is responsible for ensuring all master service agreement and quality agreement deliverables are implemented per those respective contract terms.

    What you'll do

    Leads the day-to-day Quality and Compliance Team operations at one or more account sites. Monitors operations at each site and resolves compliance status with regards to local and global regulatory standards as well as client specific requirements as defined in the master service agreement or Quality Agreement.

    Delivers and implements the CBRE compliance program and/or the client's compliance program. Attends Quality Forum monthly meetings to provide in-depth explanations for monthly reports and department metrics. Leads and participates in continuous improvement objects for both CBRE and the client.

    Interfaces, partners, and interacts with both CBRE and the clients functional areas and leadership teams. Appropriately communicates quality and compliance initiatives and/or issues across the functional areas impacted. Responsible for reporting Compliance (among other quality and business metrics) status to the client during review meetings. Appropriately raises and notifies CBRE and client management of quality and compliance issues.

    Responsible for the inspection readiness program for the site. Inspection readiness may include periodic CBRE self inspection, client self inspections, or any external agency inspections like the FDA. Has the responsibility to lead audits as well as serve as the primary quality representative for CBRE operations during external agency or client audits. Accountable to the client and/or agency for audit observations and the associated corrective measures.

    Responsible for the vendor management program for the site. Has the responsibility to ensure all GxP service providers are qualified per the CBRE regulated vendor qualification process (as well as any client directed qualification program). Accountable for approving all necessary quality agreements with third party service providers and ensuring the ongoing oversight of those vendors is performed.

    Responsible for the training and qualification program for CBRE employees. Ensures that all employees are qualified for the role they perform.

    Trains CBRE account personnel on the use of elements within the Quality Management System. Ensures the QA staff is qualified and delivering on the objectives of the QMS, annual quality plan, and the quality agreement with the client.

    Oversees the execution (maybe required to participate) and tracks the success of CBRE quality of service initiatives on the account for non-regulated services.

    Authors and negotiates terms of Quality Agreements with clients and vendors.

    Coordinates vendor management program and qualify GxP vendors, as needed.

    Investigates deviations/events, issues and manages Corrective/Preventative Actions. Participates in creation and management of changes.

    What you'll need

    Bachelor's degree or equivalent related work experience. Minimum 5+ years related work experience required. Previous experience within a quality organization within Life Science Environment(s), Facilities Management and/or Pharmaceutical/ Biotech required.

    Previous leadership experience is nice to have.

    FDA, ISO, or similar quality assurance audit related certification preferred. Must have appropriate license and/or certification where required by law.

    Prefer experience in Quality with manufacturing or utilities industries.

    Why CBRE?

    CBRE offers excellent benefits including Medical, Dental, Vision & 401k Matching Program!

    Disclaimers

    Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future.

    Pay range is approximately $120,000 - $130,000 plus 10% target bonus.

    CBRE is an equal opportunity employer that values diversity. We have a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law. We also provide reasonable accommodations, as needed, throughout the job application process. If you have a disability that inhibits your ability to apply for a position through our online application process, you may contact us via email at [email protected] or via telephone at +1 866 225 3099 (U.S.) and +1 866 388 4346 (Canada).

    Equal Employment Opportunity: CBRE is an equal opportunity employer that values diversity. We have a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.

    Candidate Accommodations: CBRE values the differences of all current and prospective employees and recognizes how every employee contributes to our company's success. CBRE provides reasonable accommodations in job application procedures for individuals with disabilities. If you require assistance due to a disability in the application or recruitment process, please submit a request via email at [email protected] or via telephone at +1 866 225 3099 (U.S.) and +1 866 388 4346 (Canada).

    NOTE: Some, but not all, of our positions may have an additional requirement to comply with COVID-19 health and safety protocols, including COVID-19 vaccination proof and/or rigorous testing. If you have questions about the requirement(s) for this position, please inform your Recruiter.

    Why you should apply for a job to CBRE:

  • 65% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.