Quality Assurance Manager

Alliston, ON
$116,480-160,160 per year
Permanent
Full-time

7 days ago

This is where your work makes a difference.At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.Here, you will find more than just a job—you will find purpose and pride.Your Role at BaxterThis is where your creativity addresses challengesYou are creative, detailed, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Assurance Manager, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.Your Team at BaxterWithin Quality, every role makes a difference. Baxter ships its products worldwide to patients in need. Whether building a new process or facing a unique production challenge, people in Quality have the trust and opportunity to be creative. No matter your role, your work will impact part of our global operation.The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to build top-of-the-line products.We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps compose a better product for our customers.What you'll be doing

Lead and manage the Quality Assurance organization to ensure compliance with the Quality Manual, Health Canada, FDA, ISO, Corporate requirements.
Provide frontline daily leadership, mentoring, and technical decision-making to resolve product quality issues.
Manage and develop direct reports while ensuring effective execution and oversight of key quality operations including shop-floor QA support, batch record review, product disposition/release decision-making, and timely escalation of quality risks
Provide independent QA supervision of Quality Control activities to ensure adherence to established standards.
Develop, implement, and maintain robust Quality Systems policies and procedures.
Serve as QA approver for validation lifecycle deliverables and provide quality technical review.
Lead and ensure timely, detailed investigations of quality/compliance events.
Facilitate and support internal and external audits and inspections including preparation, hosting, response coordination, and closure of commitments.
Establish and monitor quality/compliance KPIs, metrics, and trending to identify risks and improvement opportunities and drive continuous improvement initiatives.
Support the Quality Site Head by coordinating and tracking activities for the Site Quality Plan in partnership with cross-functional stakeholders.
Partner cross-functionally (Operations, Engineering, Supply Chain, Regulatory Affairs, Legal, etc.) to implement quality improvement initiatives and ensure alignment to site and corporate objectives.
Support Quality IT systems and tools used by the department (e.g., EBR, BaxLIMS, etc.) and ensure compliant use and data integrity.
Manage departmental resource planning, hiring, training, and the Quality budget/financial plan to ensure adequate capability and compliant execution.
Partner with Quality Engineering to support site capability-building programs (e.g., Kaizen, Greenbelt, etc.) and knowledge sharing across facilities/regions.

What you'll bring

Bachelor’s degree in a relevant scientific field; advanced degree preferred.
Minimum of 10 years of experience in quality assurance, compliance, or quality systems management within the pharmaceutical industry.
Minimum 5-7 years’ experience managing people.
In-depth knowledge of relevant regulatory requirements, including cGMP, ICH guidelines, and pharmacopeial standards.
Proven track record of successfully managing and implementing quality systems initiatives.
Experience with electronic document management systems and other quality management software tools is desirable.
Preferred Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma) is a plus.

We understand that compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
The estimated salary range for this position is $116,480 - $160,160 annually, which reflects base salary as well as estimated target payout under the Management Incentive Compensation Plan. Individual pay will be determined based upon skills, expertise and experience, and the incentive, which is contingent upon company and individual performance outcomes. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.This posting is for a current existing vacancy within our organization. We are actively seeking qualified candidates to fill this open position. If you are interviewed for this position, we will advise you within 45 days of the interview
as to whether or not you were successful in obtaining the position. Information submitted as part of the job application process will be kept on file for 3 years from the date of submission in accordance with legislative
requirements.As part of our recruitment process, Baxter Corporation may use AI tools to assist screening candidates and assist
in evaluating candidate qualifications. All final hiring decisions are made by the hiring manager and recruitment
teamEqual Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

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