Quality Assurance Manager (Remote - Quebec / Ontario)

Gilead Sciences; Ontario; Remote; CAD 80,000 - 110,000; Full time

Job summary

An innovative firm is seeking a Quality Assurance Manager to join its dynamic team in Ontario. This remote role offers the chance to lead quality and regulatory compliance for cutting-edge cancer immunotherapies. As a key player in a fast-paced environment, you will oversee product complaint management, ensure adherence to regulatory standards, and collaborate with cross-functional teams. The ideal candidate will possess a strong background in pharmaceutical quality, excellent communication skills, and a commitment to maintaining high standards of compliance. Join this mission-driven organization and contribute to transformative healthcare solutions.

Qualifications

• 6+ years of pharmaceutical quality experience in manufacturing or distribution.
• Knowledge of QA systems and Health Canada Good Manufacturing Practices.

Responsibilities

• Oversee product complaint management and quality compliance activities.
• Compile and review product reports for Health Canada submissions.

Skills

Pharmaceutical Quality Experience

Bilingual Proficiency (French and English)

Excellent Communication Skills

Regulatory Compliance Knowledge

Organizational Skills

Attention to Detail

Education

Bachelor’s Degree in Life Sciences

Engineering Degree

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Kite, a Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit a highly motivated individual, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

We are looking for a Quality Assurance Manager to join Gilead Sciences Canada affiliate Quality Assurance team. This position will be responsible to support Canada quality and regulatory compliance activities.

This is a remote role and can be based anywhere in Canada, preferably Quebec or Ontario.

Key responsibilities include :

Release Kite products imported for distribution in Canada

Oversee all aspects and execution related to product complaint management for Canadian product complaints that includes review and approval of investigations

Review and approve Annual Product Reports

Compile, review and approve Yearly Biologic Product Reports and coordinate submissions of reports to Health Canada

Support activities associated with the maintenance of Drug Establishment Licence for Kite imported products that includes foreign buildings involved in licensable activities

Perform Importer quality product annual lifecycle activities such as batch records and ongoing stability reviews

Initiate, review, approve, as applicable change control and deviation quality records

Oversee quality management system for importer / distributor regulatory requirements that may include maintenance and implementation of standard operating procedures to comply with Health Canada regulatory requirements and Kite expectations

Perform selection audits and qualify and monitor apheresis and treatment centers (ATCs) to qualification requirements.

Assist in the management of ATCs that includes training and changes management.

Support inspection readiness plans and participates in audits and inspections

Works collaboratively with Gilead / Kite team in Quality, Regulatory Affairs, Supply Chain, Manufacturing and Commercial organizations to effectively execute tasks and to participate in projects representing Gilead Canada affiliate

Ability to travel up to 30% in Canada

Identify and implement defined goals and objectives aligned with Gilead / Kite strategic initiatives

Perform other duties as assigned

Knowledge, Experience and Skills

Bachelor’s degree in Life Sciences, Engineering or equivalent

Minimum 6 years of pharmaceutical quality experience in a manufacturing or import / distribution settings; biological drug product experience is preferred

Excellent communication and presentation skills with bilingual proficiency (French and English) is a requirement

Comprehensive knowledge of QA systems, manufacturing and testing processes and related regulatory requirements including Health Canada Good Manufacturing Practices

Ability to adapt to change to meet objective / deadlines and business priorities

Ability to work with a high level of integrity, accuracy, and attention to detail to consistently meet high standards required in compliance

Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments

Excellent judgement and personal initiative

Ability to work alone and in cross functional teams

Demonstrates excellent verbal, written, and interpersonal communication skills

For jobs in the United States :

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For jobs in France :

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Quality Assurance Manager • Ontario East, Ontario, Canada