Quality Standard Manager - Jobs in Saint-Laurent, QC

Job Description

Site Name: USA - New Jersey - Warren, Canada - Ontario - Mississauga, Guayama JV, Saint Laurent Montreal, USA - Missouri - St. Louis, USA - Nebraska - Lincoln, USA - New York - Oak HillPosted Date: Nov 16 2021The Quality Standard Manager provides quality leadership and direction to sites and above site functions for the North American Quality Management System (QMS).The purpose of this role is to set the Quality Standards and Compliance for the Consumer Health business units, direct the quality development performance and governance, as well as retaining a targeted expertise group for input and review of processes and standards. This role has accountability for the effective and efficient implementation of a Fit-for Purpose QMS system; with the aim to continuously improve, streamline and simplify the standards and processes for ease of adoption and sustainability by the sites and above site functions.Ensure the local quality units processes and procedures are aligned with global QMS and that QMS is utilized to monitor compliance with product safety, quality and efficacy and that new updates and policies are deployed in a timely manner.In addition to evaluating the effectiveness of the QMS, maintaining good regulatory standing and customer certification (eg. NSF). This role will initiate required improvements and support Quality Regulatory Intelligence (QRI) activities. While positively influencing the quality culture and supporting appropriate ways of working across NA to ensure QMS is effectively implemented and ‘in-use’.This role requires a strong working relationship with the Core QMS & Quality Regulatory Intelligence (QRI) central quality teams. In order to enable a productive working environment and ensure relevant standards, guidelines and processes to deliver our NA quality plan objectives. To drive education and awareness of systems and programs this role requires close collaboration with NA Quality System Manager, Site Quality Heads, QMS champions and liaison with QMS SME’s, Process Owners and QMS Reviewers, as well as retaining a targeted expertise group for input and review of systems and processes.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Standards & Guidelines:To act as the main point of contact between the Central QMS & QRI Team, NA QMS Champions, Process Owners and Reviewers for effective communication of existing, new or revised QMS requirements. Define the NA regulatory compliance requirement and business expectations for globally deployed processes. Set-up and maintain fit-for purpose QMS governance to enable and ensure gap analyses are conducted, and risks associated with gaps are assessed and action plans to address risks are established in accordance with QMS.Quality, Risk & Compliance:Accountable for ensuring proper identification, escalation and cascade of significant QMS or QRI process risks and issues related to QMS implementation. Ensure timely escalation of critical Good Manufacturing Practices/Good Distribution Practices compliance/regulatory risks and gaps. Support the development of timely resolutions to rectify issues encountered that may result in operational failure, delays or compliance risks. Provide regular reports on progress against gap closure action plan and ongoing QMS ‘in place’ and ‘in use’ performance, for Quality Council reviews.Ensure a robust mechanism for sustaining conformance of the QMS requirements has been established and remains effective and local audit processes routinely assess QMS ‘in place’ and ‘in use’ status. Support the development, and where relevant, the implementation and execution and monitoring of the NA Quality Plan and Yearly Operating Plan setting with a focus on compliance processes. Share and publicize achievements and QMS implementation successes, recognizing in conjunction with the QLT.Processes & Tools:Defining road map of short, medium & long-term plans to drive process improvement and effective across the NA quality organization. Ensure close collaboration with all quality teams to align on quality reporting and oversight on metrics, KPIs and trends related to audit, inspection, deviations/issues, and quality performance related to QMS.Act as a liaison with stakeholders to create an integrated environment for QRI management. Engage as Quality Lead for transformational projects, QMS process changes that impact the wider quality and supply chain organization, as appropriate. Making sure that the customer/consumer’s voice is represented and presenting the NA quality leadership teams with customer/consumer experience feedback.Define and implement mechanisms to maintain and improve the quality and regulatory intelligence programs across the NA BU functions and manufacturing sites. Maintain documentation and/or associated tools to support a NA quality regulatory intelligence program.Education & Awareness:Establish and maintain, as needed, a network of Subject Matter Expert’s across NA to engage them in the QMS processes, as well as to share learning’s and best practices and support on improvement initiatives. Embedding continuous improvement and simplification through review of existing processes.Separation Activities:Support global defined QMS separation strategy, ensuring QMS approaches are easy to maintain and support inspections and audits. Ensure guidance and training materials are readily available, simple to use, and assist the QMS champions in initiating and executing their records with ease.Why youBasic Qualifications:We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree
• 5 + years’ experience in a quality, engineering, supply chain or technical role in a pharmaceutical, healthcare, or consumer goods industry
• Experience in FDA and/or Health Canada inspections

Preferred Qualifications:If you have the following characteristics, it would be a plus:

• Master’s degree

Why GSKOur values and expectations are at the heart of everything we do and form an important part of our culture.These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.Important notice to Employment businesses/ AgenciesGSK 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 GSKs 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. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.Quick Apply

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