Quality Specialist

Please note: Please note that visa sponsorship or relocation will not be offered for this position.

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Advil, Voltaren, Robax, NeoCitran, Buckley’s, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question. 

We encourage applicants with accessibility needs to notify us if they have any accommodation needs during the application and/or interview process. Please visit www.haleon.com/accessibility to learn more about our commitment to accessibility.

Job Purpose:
Responsible for the execution of LOC Quality operational processes and systems across the Local Operating Company ensuring that they are executed in compliance with HALEON policies and standards, GxP and regulatory requirements.

The function is important in maintaining timely, effective and compliant management of activities that have a direct impact to product quality, regulatory compliance and product supply to the local market. The job holder is expected to manage all assigned operational quality activities. This includes, but is not limited to, end to end product lifecycle management through support of innovation and product launch, batch disposition, change management, deviation/non-conformance investigation and root cause analysis, and post-market complaint surveillance.

Using an active customer and consumer focused mindset, the job holder will seek to generate creative solutions for technical problems, engage with line management and cross-functional stakeholders, deliver on-time commitments and continuous improvements, while maintaining adherence to HALEON values and expectations.
 

Why Join Haleon?

• Competitive compensation and annual bonus package.
• Comprehensive and flexible benefits program from day 1.
• Defined contribution pension plan with employer matching.
• Optional Haleon Savings Plan with employer matching.
• We offer all new parents at Haleon 26 weeks of fully paid leave, regardless of gender or sexuality.
• Inclusive, diverse, and collaborative culture.
• Commitment to development and career progression.
• Hybrid model in a modern office located in Mississauga.
• Fitness centre, annual fitness subsidy, and bistro onsite.

Key Responsibilities:

This role will provide YOU with the opportunity to lead key activities to progress your career. These responsibilities include some of the following…

Local Market Product Release (as assigned):

• Manage all operational product quality activities and compliance for assigned products received from HALEON sites, CMO sites and local repackers that supply product to the Canadian market.
• Responsible for local market product release, product returns, opening and investigation of deviations and change controls, as required, for all assigned products including API, bulks, intermediates, repacks and finished product as applicable.
• Support the product lifecycle by participating on new product launch teams, project execution teams and business maintenance projects and by building quality, compliance and speed to market considerations into the development process.
• Assist with measuring batch release metrics as required and drive continuous improvement cycle.

Local Market Complaint Handling (as assigned):

• Support the product safety function by facilitating the investigation of consumer adverse events and quality complaints as required for assigned products.
• Support the complaint handling system through the timely triage and assessment, processing, distribution of information, sample management and complaint closure for assigned CH Canada products.
• Assist with measuring complaints and support trending activities, including monitoring and reporting, as required and drive continuous improvement cycle.
• Support the overall complaints management process including inspection and routing of complaint samples, identification and escalation of unusual trends.
• Ensure follow[1]ups with NA Consumer Relations hub are completed in a timely manner. Ensure consumer responses are robust, meet consumer needs and are delivered in accordance with required timelines.

Additional Responsibilities:

• Support timely records retention, archival and destruction practices in accordance with the HALEON records retention schedule. Ensure robust documentation management practices in accordance with ALCOA principles and maintaining data integrity for created records.
• Support internal self-inspections and independent business monitoring audits, above-site corporate inspection and regulatory inspections (Health Canada) as required and implement assigned CAPA according to defined timelines.
• Complete assigned workload in accordance with defined targets while maintaining consistent, quality work and compliance with procedures and regulations.
• Maintain awareness of the most current GMP practices and regulatory agency compliance enforcement trends that are applicable to HALEON Consumer Healthcare Canada.
• Work with quality organizations at HALEON sites and the CMO organization to negotiate agreement on quality improvements and on the priorities and timeframes for correction of compliance deficiencies to support product supply to the Canada market.
• Provide input as subject matter expert for the creation, revision of local standard operating procedures, work instructions, reference documents and forms as required.
• Act as a peer leader within the quality team and role model by exhibiting the HALEON values and expectations. Provide ongoing education on Quality to relevant commercial functions, to increase understanding of requirements and to build Quality Culture.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Complete and Satisfactory Second Level of Education (Bachelors degree in related life sciences discipline).
• Minimum of 3 years’ experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a quality specialist.
• Knowledge of regulatory requirements pertaining to GMP.
• Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control, change management and post-market surveillance.
• Knowledge on effective quality documentation systems
• Professional written and verbal communication skills.
• Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization.
• Analytical mind, good attention to detail and problem solving skills within a structured process.
• In depth knowledge of Canadian GMP requirements related to assigned product portfolio.
• Good team player – works well in cross-functional teams.
• Good time management skills, with ability to multi-task and work under pressure.
• Strong interpersonal and negotiation skills.
• Ability to self-motivate and be resilient and focused under pressure.
• Able to work effectively in English.
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook. Experience with SAP ERP systems

Preferred Qualifications:

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

• Advanced degree/diploma/certification in a related field an asset.

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Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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Haleon is an Equal Opportunity Employer. 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.
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, Haleon may be required to capture and report expenses Haleon 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 Haleon’s compliance to all federal and state US Transparency requirements.