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Benefits

Competitive salary

Competitive salary

Short-term disability insurance Your are admissible to the short term disability plan (STD) after having completed three (3) months of continuous service as a permanent employee.

Short-term disability insurance

Your are admissible to the short term disability plan (STD) after having completed three (3) months of continuous service as a permanent employee.

Vision care insurance Your are admissible as of your first day of employment.

1) Eye examination once every 24 months
2) glasses and prescritpion: $200/24 months for adults and $200/12 months for children under 18 years old.

Vision care insurance

Your are admissible as of your first day of employment.

1) Eye examination once every 24 months
2) glasses and prescritpion: $200/24 months for adults and $200/12 months for children under 18 years old.

Description

Jubilant DraxImage, a subsidiary of Jubilant Pharma Holdings Inc, is currently recruiting for a Manager, Compliance position to join our growing team!

What can we offer?

A culture that values opportunity for professional growth and development,highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.

Jubilant DraxImage Inc. is a rapidly growing company with offices in Kirkland, QC and Yardley, PA. A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team. Jubilant DraxImage is a proud member of the Jubilant Pharma family. For more information, visit www.draximage.com

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.

If you’re up for a rewarding challenge, we invite you to take the first step and apply today!

Jubilant Pharma Holdings Inc and all our subsidiaries proudly embraces diversity in our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We have an inclusive environment where our employees can thrive and where our differences are welcomed. By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.

  • Directs activities, such as Audit and Vendor Qualification Programs, to ensure sustainable compliance to customer and Jubilant requirements as well as governmental regulations.
  • Oversees implementation of regulatory agencies regulations and Jubilant policies and procedures throughout the operations. Provides direction and manages compliance efforts in ensuring that Quality Systems meet requirements.
  • Ensures quality and GMP compliance through a comprehensive system of independent auditing of all Production, Facility and Quality Assurance / Control functions. Tracks and trends compliance issues and CAPA to ensure consistency within Jubilant sites. Conducts follow-up activities.
  • Heads regulatory agency (pre-approval and routine) and third-party inspections (routine) and assists with compliance-related verbal and written communications to any regulatory agencies.
  • Recruits and trains staff to carry out functions of the GMP Compliance Unit. Periodically reviews the performance of direct reports with regards to the achievement of goals, objectives and key performance indicators.
  • Brings to the attention of the Director, Quality Operations and Site Leadership Team, information relating to the impact of legislation.
  • Monitors expenses to ensure operations remain within forecasted budgets. Informs immediately of all potential recalls and / or critical issues on functions of the sites.
  • Manages activities related to Health Canada’s Importer of Record requirements for active pharmaceutical ingredients.
  • Tracks site KPIs for reporting to Global Quality.
  • Manages the site’s risk assessment process.
  • Responsible for the management escalation process.
  • Oversees regulatory affairs activities, i.e.: supporting client submissions registration updates, maintain Site Reference Files and Regulatory agencies requests.
  • Performs additional duties as assigned by Management.
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Work environment

Requested skills

  • Minimum BSc - specialization in Microbiology or Chemistry or closely related discipline.
  • Minimum of ten (10) years of experience in Quality Assurance / Control and Compliance within the pharmaceutical or healthcare industry, with at least five (5) years in GMP auditing experience, and three to five (3-5) years in a management role.
  • Experience in dealing with regulatory agencies.
  • Broad experience with regulatory and GMP standards associated with process control and validation, manufacturing and packaging, testing, with strong knowledge of Canadian, European and American regulations.
  • Thorough understanding of the pharmaceutical development process that leads through to commercial manufacturing and the associated GMP requirements.
  • Strong interpersonal, communication, and organization skills and problem solving ability.
  • Computer literacy (Microsoft Office & SAP environment)
  • Bilingual (French & English). Proficiency in English is essential.

Commissions

Commissions or performance bonus program offered

Requirements

Level of education

undetermined

Diploma

Completed

Work experience (years)

10+ years

Written languages

Fr : Advanced
En : Advanced

Spoken languages

Fr : Advanced
En : Advanced