Senior Regulatory Compliance and Enforcement Officer/Senior Regulatory C and E Specialist

Important messages

We are committed to providing an inclusive and barrier-free work environment, starting with the hiring process. If you need to be accommodated during any phase of the evaluation process, please use the Contact information below to request special accommodation. All information received in relation to accommodation will be kept confidential.

Information on accommodation for persons with disabilities

At Health Canada (HC), you can be part of a dynamic and multi-disciplinary team of individuals who help protect the health and safety of Canadians. Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety. Health Canada is not a manufacturer or distributor of drugs and health products, it is the federal regulator.

We are currently looking for scientific and compliance specialists to join our team. If you have been working in the pharmaceutical industry and have considerable experience in the manufacturing and quality control of drug products, join our team now as Senior Regulatory Compliance and Enforcement Officer, (in the functional position of a GMP Inspector, (Good Manufacturing Practices Inspector) or as a Regulatory Compliance and Enforcement Specialist, (in the functional position of GMP Inspector-Specialist).

Senior Regulatory Compliance and Enforcement Officers and Specialists, through domestic and international efforts, play a significant role in ensuring that the drug products that are made available on the Canadian market are up to our standards. You will be challenged in a very fast paced environment, travelling through our country and the globe to assess the good manufacturing practices of the supply chain of drug products. You can help ensure that the drugs available in Canada have been manufacturing, tested, stored and transported as per our regulations.

We are proud of our growing national team and team spirit, and we provide opportunities to collaborate, learn and grow, not only internally but through work sharing initiatives with other regulators across the globe. Health Canada encourages a work-life balance. Teleworking, compressed work hours, and a valuable pension plan are some of the many possibilities and benefits of being a public servant.

What better time than now to work for HC and contribute to the protection of all Canadians. Come join us!

Positions to be filled: 1

Information you must provide

Your résumé.

A covering letter in 1,000 words (maximum)

In order to be considered, your application must clearly explain how you meet the following (essential qualifications)

Education:
Bachelor’s degree from a recognized post-secondary institution with acceptable specialization in microbiology, chemistry, engineering, or some other specialty related to the position.

Degree equivalency

Experience: Applicants are encouraged to apply to both positions if they meet the essential experience.

For SG-04 positions
E1: Recent* and significant** work experience in the pharmaceutical industry of marketed drug products in production, quality assurance, quality control, or validation.

* Recent experience is defined as three (3) years within the last five (5) years.
** Significant experience is defined as being directly involved with GMP manufacturing and/or quality control operations.

For SG-SRE-05 positions only:
E2: Recent and significant work experience* in the pharmaceutical industry of marketed drug products in production, quality assurance, quality control, or validation.

* Recent and significant experience is defined as seven (7) years within the last ten (10) years being directly involved (decision-making level or providing advice to decision making level) with GMP manufacturing and/or quality control operations.

Or

E1 from SG-04 essential qualification combined with:
E3: Recent and significant experience** related to sterile product manufacturing or quality assurance or quality control in compliance with established standards/regulations.***

** Recent experience is defined as five (5) years within the last eight (8) years.
*** A written exam will be used to assess this asset.

The following will be applied / assessed at a later date (essential for the job)

Bilingual - Imperative (BBB/BBB)

Information on language requirements

Knowledge:
K1: Knowledge of the Good Manufacturing Practices regarding marketed drug products and active pharmaceutical ingredients, (APIs) as related to the manufacturing, testing, storage and distribution activities, GUI-0001, GUI-0104 and all other related GMP guidelines.

K2: Knowledge of Health Canada’s approach to Compliance and Enforcement, POL-0001.

Competencies:
C1: Thinking and Acting
C2: Focus on service
C3: Commitment and Ethics
C4: Interpersonal Relations
C5: Team Work
C6: Respect for Diversity
C7: Oral Communication
C8: Written Communication

The following may be applied / assessed at a later date (may be needed for the job)

Experience:
A1 – Work experience** in the inspection or execution of compliance and enforcement activities related to drugs subject to the Food and Drugs Act and its associated regulations at Health Canada, specifically related to GMP – Division 2, Part C.

A2: Work Experience** related to sterile product manufacturing or quality assurance or quality control in compliance with established standards/regulations.

A3: Working experience** related to biotechnology product manufacturing or quality control in compliance with established standards/regulations.

A4: Working experience** related to radiopharmaceutical product manufacturing or quality control in compliance with established standards/regulations.

A5: Working experience** in computerized systems validation such as JDEdwards, SAP, Trackwise or other.

A6: Working experience** in cleaning process validation and/or product process validation.

A7: Working experience** in participating on various stages of a project such as initiating, planning, organizing, monitoring and controlling, reporting, communication or closing.

A8: Working experience in contributing to the development of operating procedures, guidelines or policies.

** Working experience is defined as a minimum of one (1) year within the last three (3) years.

Organizational Needs:
Selection may be limited to members of the following Employment Equity groups: Aboriginal persons, persons with disabilities, visible minorities, women.

Conditions of employment

Reliability Status security clearance

Valid driver's license and personal mobility to the degree normally associated with possession of a valid driver's license;
Willingness and ability to travel within* and outside Canada, up to 30% of time, (* does not include regional travel, i.e. within the province of Québec.);
Willingness and ability to work overtime evenings and weekends occasionally;

Other information

The Public Service of Canada is committed to building a skilled and diverse workforce that reflects the Canadians we serve. We promote employment equity and encourage you to indicate if you belong to one of the targeted groups when you apply.

Information on employment equity

Your résumé and a cover letter. Your written communication skills will be evaluated through your cover letter.

You must meet all essential qualifications in order to be appointed to the position. Other qualifications may be a deciding factor in choosing the person to be appointed. Some essential and other qualifications will be assessed through your application. It is your responsibility to provide concrete examples that illustrate how you meet each qualification. Failing to do so could result in your application being rejected.

A minimum of two professional references will be requested and checked, one of which must be an immediate supervisor (for a minimum of 6 months) within the last 5 years of employment.

Preference

Preference will be given to veterans and to Canadian citizens, in that order.

Information on the preference to veterans

We thank all those who apply. Only those selected for further consideration will be contacted.