At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Quality Assurance Specialist Change Management 

The QA Specialist – Change Management as a member of the Quality Systems Community is responsible for the change management process, ensuring stringent compliance with local, corporate, and regulatory requirements. Your role will involve managing the full lifecycle of changes driving procedural excellence and fostering cross-functional collaboration.
 

This role is dedicated to the Canadian requirements as part of the Quality Assurance organization in Canada. Use of this resource outside of Canada requires CQH Canada agreement.

Bayer is committed to a flexible hybrid working environment. This is a 14-month term position which can be a Development Assignment or a Contract position, based out of Mississauga, ON.

What you will do:

• Manage the lifecycle of change requests by opening and closing changes in the system, ensuring all necessary documentation is accurately completed.

• Review change documentation to ensure compliance with Canadian quality standards, including the assessment of risk, impact, and required approvals.

• Ensure that all changes are properly evaluated, implemented, and documented, with effective follow-up to ensure no issues are left unresolved.

• Actively track and monitor additional approvers and related tasks to ensure all approvals are obtained in a timely manner.

• Communicate with stakeholders to expedite approvals and ensure the proper workflow of tasks related to change management.
• Initiate and document local changes, collaborating with cross-functional teams to ensure all local requirements are met.

• Maintain an up-to-date record of all local changes and track their progress through the change control system.

• Provide recommendations for mitigating compliance risks related to changes in the pharmaceutical production and quality environment.

• Ensure the timely review and implementation of assigned global procedures and Health Canada regulations within your community.

• Provide support to other team members or Community as needed, offering expertise and/or assistance to ensure cross-functional collaboration and the successful completion of shared objectives and outcomes.

• Collect and analyze data for KPIs of the systems under your responsibility to evaluate the system performance, providing insights to drive improvements and efficiencies. Apply an entrepreneurial retrospective to the Community Senior Specialist/ Lead.

• Develop, implement, and maintain Canadian procedures for which you are the owner/author. Ensure these procedures align with corporate and regulatory standards, continuously improving processes to enhance efficiency and compliance.

• Prepare thoroughly for audits and inspections of the systems under your responsibility. Define and oversee the implementation of appropriate corrective and preventive actions (CAPAs) based on audit observations and findings, ensuring timely resolution.

• Participate in a manner that fosters a culture of inclusion, continuous improvement, and accountability.

Who you are:

• University Degree or college Diploma in science (e.g. Chemistry, Biochemistry, Microbiology)

• Minimum of 7 years of experience in a pharmaceutical or regulated industry, with a focus on change management and quality assurance.

• Strong knowledge of pharmaceutical quality systems, change control processes, and Health Canada regulatory requirements.

• Advanced knowledge of data integrity principles, good manufacturing practices, risk management and Health Canada regulatory guidelines and regulations.

• Strong project management, leadership, interpersonal skills and technical writing skills.

• High level of accountability, collaborative with an enabling and entrepreneurial mindset.

• Fast learning, action-oriented and agile.

• Strong communication and interpersonal skills for effective collaboration across departments.

• Proficiency in change management software and systems.

• Experience working in a pharmaceutical manufacturing environment is an asset.
  
  

What we offer:

• Competitive compensation and rewards package.
• Collaborative, diverse and inclusive culture.
• Career development and global opportunities.
• Work-life flexibility programs such as flex hours, employee discounts, volunteer days, wellness, and other employee offerings.

Bayer is committed to fostering, cultivating and preserving a culture of Inclusion and Diversity. We embrace and encourage our employees’ differences and believe that our people are our most valuable asset. The collective sum of individual life experiences, knowledge, innovation, self-expression, unique capabilities that our employees invest in their work represents our culture, reputation, and Bayer’s values and purpose.

All referral candidates must first be submitted via our internal referral system by a current Bayer employee in order to participate in the referral program. Once a Bayer employee has successfully referred you in our system, you will receive an automated email with instructions on how to complete your application.

This posting will be available for application until at least .June 23, 2025

#LI-CA

Bayer welcomes and encourages applications from people with disabilities. Candidates participating in our selection process requiring accommodation due to a disability or medical need are encouraged to notify the Bayer representative that they will be meeting with to ensure appropriate arrangements can be made.

Location:

Canada : Ontario : Mississauga  

Division:

Pharmaceuticals 

Reference Code:

847529