Head Pharmaceutical Quality And Regulatory Affairs, Pni And Genomic Medicines

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:

The Head of Quality and Regulatory Affairs is a tenured and experienced individual in biological drug product manufacturing responsible for providing key leadership, vision, organizational direction, change management, compliance monitoring, cGMP compliance, and function as independent and objective subject matter expert responsible at both a strategic and tactical level.

This role will lead the Genomic Medicine pharmaceutical QMS, accountable for the development and implementation of a Cytiva best in class quality program at PNI and concurrently harmonizing across the pharma regulated Gen Med Opco. This individual will pursue proactive enhancement of all aspects of compliance, quality, and risk management. The successful candidate must be able to build a strong, effective, and diverse team to support the ever-changing global regulatory landscape and ensure that the quality needs of our clients are met. This individual must understand how to build strong relationships with both domestic and international regulatory authorities and be comfortable supporting regulatory or client audits.

Primary Responsibility:

• Maintains effective and collaborative internal customer relationships
• Proactively identify potential quality risk areas and then drive the implementation of appropriate corrective and preventive actions
• Provide daily leadership and management for the teams that report into this position to drive excellence in quality related functions.
• Interacts with clients and key stakeholders internally to address and resolve difficult Quality problems.
• Works productively with cross functional teams within the organization in order to proactively resolve issues.
• Lead and support all PNI Quality Assurance, Quality Control, and Regulatory Affairs activities and functions.
• Acts as primary liaison and coordinates meetings with FDA and other health authorities as needed, representing the company with those agencies.
• Oversees activities in support of clients INDs, NDAs, and other regulatory submissions.
• Accountable for Quality Governance, Quality Escalation and Quality Management Review processes.
• Participate in any issues that require management escalations
• Develops and implements comprehensive regulatory, clinical, and commercial quality strategies related to Cytiva Genmed pharmaceutical operations and PNI biopharma services clients.
• Develop the technical, Quality, and business acumen of the PNI Quality and Regulatory Affairs department.
• Ensure that all company, client, regulatory, and statutory requirements are met before full PNI product release
• Coordinate and host customer audits and develop audit responses as the need arises by the respective auditing customer.
• Manage Regulatory and Quality personnel in accordance with Company talent management practices. Train, mentor, and coach the staff within the department
• Provide support for internal projects in order to ensure that everything is appropriately documented.
• Communicate regulatory compliance requirements and the company’s Quality standards to the entire Quality team, Site Managers, and the Site Leadership Team & wider Cytiva QARA organization.
• Designing, implementing, harmonizing and systemically reviewing the Cytiva Pharma Quality Management System (QMS), starting with PNI.
• Additional responsibilities as assigned
• Accountable for the Quality Manual(s), Quality Plan(s), Site Master File (SMFs)
• Interact and partner with our operational counterparts to build strong relationships, to enhance and improve our Quality culture, and reduce the number of non-conforming events encountered during manufacturing.
• Works with leadership to incorporate implications of international regulatory strategy to GxP compliance policies and operations
• Drive the development and implementation of new processes and procedures that will enhance efficiency and compliance
• Maintains strong communication networks with peers

Qualifications and Experience:

• Good interpersonal skills with the ability to influence others across multiple functions.
• 15+ years of experience in GMP manufacturing, Quality Assurance or Quality Control area in the pharmaceutical industry, with at least 5 years in a leading position.
• Ability to apply compliance standards to daily production situation.
• Willing to consider remote work to candidates in North America, must be willing to travel to Vancouver 1 week per month.
• 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).
• Experienced with hosting foreign and domestic regulatory inspections (US-FDA EU Authorities).
• M.S. or Ph.D. degree in chemical or biological sciences, pharmaceutical technology, chemical engineering, or equivalent experience.
• Experience with due diligence, Mergers and Acquisitions and integration.
• 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.