Lead QA Specialist - Vancouver, Canada - Danaher Corporation

Description

Be part of something altogether life-changing

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Lead QA Specialist for Cytiva is responsible for being the Team Lead for a growing team of QA Operations personnel for the Pharmaceutical GMP Manufacturing operations with key areas of focus including, but not limited to: supporting client projects from preclinical through development to GMP drug substance/drug product manufacturing, in-plant QA activities for manufacturing, batch record and data review, material and product disposition, external manufacturing oversight, approval of operational documents, etc.

This position is part of the Quality Assurance department located in Vancouver, BC, Canada and will be hybrid, eventually transitioning to on-site. At Cytiva, our vision is to advance future therapeutics from discovery to clinical.

What you'll do:

• Act as Team Lead within a growing team of QA Operations personnel.
• Perform disposition activities for clinical drug products and drug substances.
• Provide quality & compliance oversight and direction in support of the operational design of the planned Biomanufacturing Centre for pharmaceutical CDMO activities.
• Evaluate Cytiva corporate quality and operational programs for suitability for integration and implementation at the site for GMP pharmaceutical CDMO operations.
• Collaborate with Quality Systems and QA Validation teams to ensure holistic quality strategies across the GMP operations. Who you are:
• Undergraduate education in basic or applied science (chemistry, biological sciences, pharmacology, pharmaceutical science). Masters degree preferred.
• 10 – 15 years of experience in a pharmaceutical or biotech environment required
• A practical working knowledge of computers, computer software applications, and data management is necessary
• A solid understanding of applicable regulations and guidelines as well as experience with global GMPs for sterile Clinical Trial medicinal products in a working manufacturing environment are required.
• Strong desire to influence and coach. Able to demonstrate and teach not just the how, but the why and develop a culture where everyone owns Quality.

It would be a plus if you also possess previous experience in:

• Performing gap and risk assessments with an eye to inspection and audit readiness
• Implementing or utilizing Oracle ERP, a PLM for item/parts master data management, and Veeva for document and quality event management.
• Certified Quality Auditor (CQA) certification

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

The salary range for this role is $88,600 - $154,900 CAD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and retirement plans to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

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At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.