GSK Hiring for Quality Manager, Canada Rx Market Supply Quality at Mississauga, ON Full Time

WHY GSK?

Our Pharmaceutical Supply Chain (PSC) business is responsible for making and supplying our pharmaceutical and biopharmaceutical products around the globe. The PSC organisation is involved with every production stage from the infrastructure of the manufacturing sites, supply forecasting, regulatory inspections, and the product’s quality.

We operate across 28 sites in 16 countries. Over the past three years, we have become even more reliable and competitive, increasing our productivity by over 20%. We are building an agile network that delivers the next generation of medicines for patients, developing an exciting pipeline of specialty medicines and vaccines as technology transforms what is possible in pharmaceutical manufacturing. A pipeline of specialty medicines will require a different supply chain, which will demand the right capabilities and capacity. Automation and Robotics play a key role in all this, and we will increasingly have the tools at our disposal to work smarter and more efficiently.

We’re taking bold steps on inventory, productivity, and procurement to maintain a balanced scorecard and provide the cash needed to reinvest in innovation. Our ambition is to continue to advance our quality, safety, and supply standards, which enhance the trust patients, physicians, local communities, and regulators have in us.

Environmental sustainability is a vital part of our focused Environmental, Social, and Governance approach to support sustainable business performance. We’ve set new ambitious environmental sustainability goals: to be carbon net-zero and nature net positive by 2030.

PRIMARY RESPONSIBILITIES

This position is responsible for leading Quality activities associated with Canada Market Supply of prescription products. This includes providing effective and efficient quality assurance systems support to the LOC Quality Director, acts as the LOC Quality Director deputy and has oversight responsibility for a team of Quality professionals.

This includes decision making around quality incidences within Canada distribution, Complaint management, Collaboration with Health Canada on product Quality issues within the Canadian market, Recalls, Licensing and Registration, Auditing, and Batch release, APQR’s and TTS’s associated with GSK sister sites and Third party Contract Manufacturers. The position is also responsible for assessing and monitoring and making key decisions associated with Quality processes and Quality incidences in the Canadian Market, to ensure compliance with applicable regulations and GSK policies in collaboration with the LOC Quality Director.

The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance in the Canadian Market. The job interfaces directly with the commercial Canada Rx Local Operating Company to ensure that the mandated GSK Quality Management Systems (QMS) requirements for commercial operating units are met.

This position must take the lead in implementing the QMS across the LOC and also include partnering with the commercial teams to embed and sustain quality processes in their day to day work.

This position is also responsible for developing, leading, and coaching a team of technical/quality support staff. The position is responsible for establishing and maintaining a program to provide personal and professional development for the Quality staff ensuring clarity of goals and objectives and providing regular feedback on performance.

Key responsibilities include:
Provides leadership to the Quality LOC Canada Rx team

Acts as the deputy to the Quality Director LOC Canada in their absence

Provides effective and efficient quality assurance systems support to the Quality Director LOC Canada (Canada Rx and ViiV)

Responsible for people management and supporting development of 3-5 quality professionals

Responsible for setting performance objectives and managing performance of direct reports

Leads Local Incident Committee meetings as required and manages related communications and actions with LOC business partners

Represents Canada Rx on global product Incident teams and acts as recall coordinator delegate in the event of a recall

Supports the implementation and maintenance of the QMS (Quality Management System) in Canada LOC (Rx) and ensures that Local SOPs are compliant with QMS and local regulations.

Host Regulatory and/or 3rd party customer audits

Oversees metrics reporting related to KPIs and identifies trends and improvement initiatives

Supports the Quality Director LOC in the management of Quality Council

Oversee the local audit program and define the audit universe for LOC Canada Rx

Oversees quality activities for Canada Rx including Risk Management, and Quality Agreeements

Interface/communicate with Health Canada for reporting purposes or in audit environment

Provide Quality oversight /leadership for local investigations, improvement projects, new business opportunities

Review and approve documents of high complexity including complex deviation reports, annual product reviews, critical incidents

May oversee batch release, complaints, Annual product reviews, deviations , change control,

Ensures training program for quality is in place and effective.

Quality oversight of 3rd party service providers in Canada including outsourced Canadian Distribution centers

BASIC QUALIFICATIONS

Bachelor of Science or Engineering degree or equivalent

Minimum 8 years of pharmaceutical quality and/or compliance experience

Minimum 3 years of leadership / managerial experience

Comprehensive knowledge of QA systems, manufacturing and testing processes and related regulatory requirements (cGMPs)

Demonstrated risk-based decision-making skills

Demonstrated proficiency in computer systems

At least 3 years of experience with interacting with Health authorities, including inspection experience

Thorough technical and regulatory knowledge of current pharmaceutical manufacturing techniques and the applicable current regulatory and GSK requirements.

Excellent organizational and communication skills (verbal and written)

Demonstrated ability to prioritize work, adapt to change, meet objective / deadlines

Ability to work alone and in cross functional teams

“Can do” attitude and improvement mindset

PREFERRED QUALIFICATIONS

Additional qualification in a scientific field (MSC or PhD)

Experience in a previous role an importer/ distributor as defined by Health Canada’s licensable activities.

Experience in Project Management

Experience working with Supply Chain organizations and Supply Chain processes

Strong Chemistry/ Manufacturing regulatory content understanding (CMC)

Expertise in multiple computer systems, such as SAP and/ or Veeva

At least 3 years experience in cGMP auditing

Experience with direct Health Canada interaction

• LI-GSK

GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine. We feel strongly that this is the best way to help protect those we value most: our employees, families, communities and the patients and consumers we serve. To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis.

Only employees who are fully vaccinated against COVID-19 may attend our Mississauga and Laval corporate offices. In addition, all customer-facing employees who, as part of their job, attend healthcare settings such as hospitals, pharmacies, doctors’ offices and dentists’ offices will need to be fully vaccinated against COVID-19. Notwithstanding the foregoing, employees may seek an accommodation for human rights-related reasons, including medical or disability-related conditions, or religious beliefs.

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