Quality Director, Canada Rx Market Supply Quality

GlaxoSmithKline

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Be part of us in our mission to uphold the very best requirements of high quality and compliance within the Canadian pharmaceutical market! Because the chief overseeing High quality actions at GSK, you will play a pivotal position in making certain our merchandise meet Well being Canada laws and cling to our rigorous High quality Administration System. Your selections will straight impression product high quality and regulatory compliance, shaping the way forward for our operations.

Job Goal:

This position provides a novel alternative to collaborate carefully with our industrial Canada Rx Native Working Firm, implementing and refining our High quality Administration Programs. You may work alongside the Pharma Management staff, making certain Well being Canada and QMS necessities are successfully built-in on the native stage.

Past main essential processes, you will nurture and information a devoted staff of technical consultants, fostering their progress and making certain their alignment with our high quality goals. Be part of us in making a tradition of excellence, the place private {and professional} improvement are prioritized, and efficiency is regularly elevated. In case you’re able to make a profound impression and drive high quality requirements within the pharmaceutical business, we welcome your experience and management!

Particulars (Your Obligations):

This position will present YOU the chance to guide key actions to progress YOUR profession, these tasks embody among the following…

Market Launch Oversight:

  • Handle the processes concerned out there launch of GSK & ViiV merchandise inside Canada.

High quality Operations Administration:

  • Oversee and make sure the adherence to high-quality requirements at Canadian Distribution Facilities chargeable for supplying merchandise to the market.

Product Complaints Dealing with:

  • Lead the great course of addressing complaints concerning Pharma and Vaccine merchandise bought within the Canadian market, making certain environment friendly and efficient resolutions.

Drug Product Recall and Administration:

  • Direct and execute the recall course of for GSK merchandise in Canada, together with coordination of recall notifications, overseeing product return procedures, and reporting to Well being Canada on recall actions.

Technical Phrases of Provide and Compliance:

  • Handle the preparation, approval, and upkeep of Technical Phrases of Provide, making certain steady adherence to product high quality, specs, and compliance necessities.

Regulatory Documentation and Compliance:

  • Direct actions associated to Drug Itemizing documentation and keep GSK Institution Registrations for services supplying the Canadian market, making certain compliance with laws.

Auditing and Service Supplier Administration:

  • Oversee auditing actions associated to service suppliers, together with transportation and contract distribution providers, making certain adherence to high quality requirements.

Communication and Reporting:

  • Deal with efficient communication and well timed reporting of High quality incidents to Well being Canada, making certain transparency and compliance.

High quality Administration System Implementation:

  • Implement and keep High quality Administration Programs for LOC Canada Rx Industrial operations, making certain alignment with regulatory requirements.

Direct Interplay with Well being Canada:

  • Work together straight with Well being Canada to report high quality points and handle the recall course of, sustaining compliance and resolving points promptly.

Why you?

Fundamental {Qualifications}:

We’re searching for professionals with these required abilities to realize our targets:

Academic Background:

  • Bachelor’s diploma in science or engineering (Chemistry, Biology, Biotechnology, Pharmaceutical, or associated area)

Skilled Expertise:

  • Confirmed observe file as a High quality Assurance Chief/Supervisor
  • Minimal of three years of expertise in cGMP auditing or internet hosting audits, together with direct interplay with Well being Canada

Regulatory Data:

  • In-depth understanding and utility of cGMPs, Well being Canada’s Half C, Division 2 of the Meals and Drug Laws, and related steerage paperwork (e.g., GUI-0001)
  • Complete information of regulatory necessities essential to assess and make essential high quality selections affecting merchandise out there.

Technical Experience:

  • Strong grasp of present pharmaceutical manufacturing methods
  • Thorough information of present regulatory requirements.

Choice-Making Abilities:

  • Means to make essential high quality selections related to incidents that impression merchandise out there.

Administration Abilities:

  • Robust managerial expertise, able to main and creating a staff of technical/high quality help workers.
  • Demonstrated means to determine and keep applications for private {and professional} improvement inside a staff.

Communication Abilities:

  • Glorious verbal and written communication abilities
  • Robust interpersonal abilities for efficient collaboration and interplay with numerous groups and Well being Canada authorities

#LI-GSK

Why Us?

GSK is a world biopharma firm with a particular objective – to unite science, know-how and expertise to get forward of illness collectively – so we will positively impression the well being of billions of individuals and ship stronger, extra sustainable shareholder returns – as a company the place folks can thrive. Getting forward means stopping illness in addition to treating it, and we intention to positively impression the well being of two.5 billion folks by the top of 2030.

Our success completely will depend on our folks. Whereas getting forward of illness collectively is about our ambition for sufferers and shareholders, it’s additionally about making GSK a spot the place folks can thrive. We would like GSK to be a office the place everybody can really feel a way of belonging and thrive as set out in our Equal and Inclusive Remedy of Workers coverage. We’re dedicated to being extra proactive in any respect ranges in order that our workforce displays the communities we work and rent in, and our GSK management displays our GSK workforce.

GSK is an equal alternative employer dedicated to variety and inclusion. We welcome purposes from all certified people to use to our profession alternatives. GSK is dedicated to accommodating individuals with disabilities. In case you want lodging at any stage of the applying course of or need extra data on our lodging insurance policies, please contact us at [email protected]. Please don’t ship resumes to this e-mail and as an alternative apply by way of the net utility technique of this posting.

Vital discover to Employment companies/ Businesses

GSK doesn’t settle for referrals from employment companies and/or employment businesses in respect of the vacancies posted on this web site. All employment companies/businesses are required to contact GSK’s industrial and common procurement/human sources division to acquire prior written authorization earlier than referring any candidates to GSK. The acquiring of prior written authorization is a situation precedent to any settlement (verbal or written) between the employment enterprise/ company and GSK. Within the absence of such written authorization being obtained any actions undertaken by the employment enterprise/company shall be deemed to have been carried out with out the consent or contractual settlement of GSK. GSK shall due to this fact not be responsible for any charges arising from such actions or any charges arising from any referrals by employment companies/businesses in respect of the vacancies posted on this web site.

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