Quality Manager Canada

3 weeks ago

Mississauga, Canada 837 GlaxoSmithKline Inc. Full time

*Only candidates currently living in Canada, with the legal right to work her, will be considered.

Reporting to the Quality Director, this position is responsible for leading Quality activities associated with Canada Market Supply of prescription products. Do you have what it takes to make key decisions associated with Quality processes and Quality incidences in the Canadian Market?Do you excel at being responsible for developing, leading, and coaching a team of technical/quality support staff?This may be the right career fit of you

PRIMARY RESPONSIBILITIES

This 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.

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.

Key Responsibilities

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 Agreements

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 centres.

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

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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