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Manager/Senior Manager Compliance

Req #: 17000013
Location: Mississauga, ON CA
Job Category: Regulatory Affairs
Work Location: Mississauga, Ontario 6755 Mississauga Road Suite 600 Mississauga L5N 7Y2
Organization: Celgene Inc.
Schedule: Full-time
Shift: Day Job
Employee Status: Regular
Job Type: Standard
Job Level: Manager
Travel: No


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.


The Position:
Manager/Senior Manager Compliance Canada is responsible for:
  • Overall Quality System and integration of various Celgene Inc. Compliance Programs
  • Health Care Compliance (HCC) Program for Celgene Inc.
  • Fostering a culture of compliance within Celgene Inc.
  • Alignment with Celgene Global Corporate Compliance 
Essential Functions:
Affiliate Quality System
  • Responsible for overall affiliate quality system
  • Act as coordinator between various functions with regard to compliance activities to ensure alignment and consistency across HCC, GMP, GVP, GCP, Finance, Privacy and Risk Management
  • Ensure Good Affiliate Practice with respect to compliance is consistently applied across the Canadian organization
  • Build, conduct and manage internal audits upon request by Senior Management 
Health Care Compliance
  • Plan, design, operationalize, monitor and oversee the local HCC program to ensure local compliance with applicable internal and external rules and regulations (e.g., local Code(s), Corporate Policies, local specific legislation);
  • Report on a regular basis to the local HCC Board on compliance matters and assist the General Manager and the Senior Management Team’s members to establish appropriate methods to reduce the company’s HCC risks;
  • Ensure training assignments are properly deployed and reporting completion metics to General Manager and Senior Management Team.
  • Work in close cooperation with the Senior Management Team to create a culture of compliance and set the tone at the top. This includes promoting open communication where staff members feel comfortable speaking up;
  • Provide an overview of the local compliance status to global Compliance (as appropriate);
  • Periodically review the local HCC program, as appropriate, to respond to changes in the company’s needs and applicable local and global requirements, identified weakness in the program, or identified systemic patterns of noncompliance;
  • Conduct self-audit of HCC systems within the commercial, medical affairs and market access organizations as needed;
  • Develop, coordinate, and execute a multifaceted educational program that focuses on the elements of HCC to ensure all affected employees and management understand and comply with pertinent standards;
  • Review and, where appropriate, act in response to reports of noncompliance. This includes taking a leading role in establishing and implementing remedial activities for specific local HCC audit findings or other potential risk areas; interacting and following through with applicable departments and functional heads for corrective actions, preventive actions and implementation;
  • Act as key contact for local HCC audit: provide advanced information, prepare documentation, identify local functions/team members;
  • Act as key contact point for global compliance for activities in the scope of HCC. This includes local self-inspections and the review and translation (if applicable) of Corporate Policies, Regional Template SOPs, presentations, communications and trainings;
  • Represent local HCC on global, international or regional cross-functional teams, as appropriate;
  • Member of the Global Policy Committee
  • Monitor developments in applicable HCC rules and enforcement trends.

Working Conditions:

  • Head office based role in Mississauga, Ontario.




Required Competencies-Knowledge, Skills, and Abilities:
  • Bachelors degree, with a focus on Healthcare, Science, Finance or Business
  • Extensive experience in the pharmaceutical or finance industries with a combined experience of at least 5 years’ duration in any of the following functions: Health Care Compliance (HCC), Regulatory Affairs, Finance & Accounting, Quality Assurance, Drug Safety, Risk Management, Clinical Operations, Sales Training or field positions in either Sales or Medical. The Senior Manager, Compliance requires a minimum of two (2) years’ HCC experience.
  • Life sciences / pharmaceutical audit background is an asset
  • Experience with Canadian pharmaceutical industry codes is an asset

Skills/Knowledge Required:

  • Knowledge and understanding of compliance concepts
  • Strong leadership skills essential
  • Effective team building and teamwork skills
  • Ability to prioritize and manage time efficiently
  • Excellent interpersonal skills
  • Ability to influence without authority
  • Proven Project Management skills
  • Financial and business awareness
  • Excellent presentation and communication skills
  • Writing skills at the level of author (examples include and are not limited to SOP, work practices / instructions, guidance documents, audit reports, training materials, Regulatory submission documents / responses, protocols etc.)
  • Computer literate; familiarity with Microsoft Office programs, in particular: Word and Excel
  • Bilingualism (English & French) an asset



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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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