Head of Quality and Regulatory Affairs

3 days ago


Vancouver, Canada Pall Corporation Full time

About Precision NanoSystems Inc. (PNI)

Precision NanoSystems Inc., part of Pall Corporation, is a biotechnology company that creates innovative solutions for the discovery, development and manufacture of novel nanoparticles for use as medicines and in medical research. PNI’s proprietary NanoAssemblr® microfluidics platform and GenVoy® lipid nanoparticle delivery platform enable the rapid, reproducible, and scalable manufacture of next generation nanoparticle formulations for the targeted delivery of therapeutic and diagnostic agents to cells and tissues in the body. Our overall goal is to accelerate the creation of transformative medicines that significantly impact human well-being.

Position Summary:
Areas of Responsibility:

- Establish departmental goals and effectively communicate direction, objectives, and results as needed to the department, plant site, staff.
- Develop and actively manage team conformance to departmental budget and drive improved efficiencies in departmental operations.
- Develop, implement and continuously improve the quality system procedures that are effective and compliant to applicable standards.
- Establish cGMP training systems and perform on -site staff training.
- Ensure PNI meets business and customer requirements with respect to the development and transfer of testing methods for raw materials, in-process controls, and intermediate and final products.
- Complete new client questionnaires as required by the sales teams to support the development of new customer projects and products.
- Coordinate and host customer audits and develop audit responses as the need arises by the respective auditing customer.
- Coordinate and host regulatory agency audits, coordinate follow-up communication and supervise vital corrective actions on site.
- Ensure compliance with all commitments (to customers or authorities) in conjunction with regulatory approvals of products and processes.
- Establish and manage QA tracking and trending of crucial performance measures and the preparation of periodic reports for management review. Chair the Management Review meetings.

Qualifications and Experience:

- M.S. or Ph.D. degree in chemical or biological sciences, pharmaceutical technology, chemical engineering, or equivalent experience.
- 15 years of experience in GMP manufacturing, Quality Assurance / Quality Control or similar operational areas in pharmaceutical or medical device industry, with at least 5 years in a leading position.
- Experienced with hosting foreign and domestic regulatory inspections (US-FDS, EU Authorities).
- In depth knowledge of regulatory requirements, i.e. GMP, Health Canada, EU, and FDA and experience with GMP documentation review.
- Experienced in hosting customer audits and certification audits (e.g. ISO 9001, ISO 13485).
- Good interpersonal skills with the ability to influence others across multiple functions.
- Exhibits initiative to recognize and solve problems.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful

Danaher Business System

tools and the stability of a tested organization.

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.

If you’ve ever wondered what’s within you, there’s no better time to find out.



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