Vice President, Quality & Regulatory
City: Richmond, BC, Canada
Department: Regulatory Affairs
Position: Permanent, Full Time
Did you know that you no longer have to book an appointment with your doctor and wait weeks to get lab results back for STIs like HIV and Syphilis?
bioLytical’s INSTI is the world’s fastest testing platform – providing results in just 1 minute. Yes, you read that correctly – results in 1 minute not 1 to 2 weeks! We’ve been in business since 2002 and are growing significantly now with the launch of new products all over the world. bioLytical Laboratories has ranked on Business in Vancouver’s Top 100 Fastest Growing Companies list two years in a row and is the winner of the 2018 Lifesciences BC’s Growth Stage MedTech Company of the Year.
The full suite of INSTI tests are greater than 99% accurate and have a world-wide footprint of regulatory approvals including US FDA, Health Canada, World Health Organization Prequalification and CE mark for Europe. bioLytical markets its HIV point-of-care tests, HIV self-tests and dual HIV/Syphilis Multiplex point-of-care tests globally with a strong product pipeline from our research team. INSTI is the world’s fastest test, which means more people tested, more people diagnosed and more people linked to care.
We are looking for talented and passionate people to join us on our mission to end AIDS. With millions of tests already sold, INSTI is trusted by healthcare professionals and recently available to consumers. Come join us on our journey and help make a difference in the world!
This newly created position holds ultimate responsibility for the quality and regulatory functions including defining and implementing long term strategies to support bioLytical’s manufacturing operations and meet corporate objectives. The VP, Q&R requires the ability to analyze complex technical and medical information for problem solving and ability to liaise confidently with Auditing Organizations and Regulatory Agencies such as the US FDA, Health Canada and other International Health Authorities.
WHY CONSIDER THE OPPORTUNITY:
The Vice President, Quality & Regulatory is a newly created position which will be instrumental in helping bioLytical realize its vision of building a high-quality, cost effective suite of rapid point-of care-tests.
- The Vice President, Quality & Regulatory (VP, Q&R) reports to the Chief Operating Officer
- The Quality Assurance Manager, Quality Control Manager and Regulatory Affairs Manager are direct reports to the VP, Q&R
You will develop and coordinate system-wide processes and activities to optimize efforts in quality and continuous improvement. Contained within this broad scope will be oversight and accountability for continual best practices in accreditation, risk management, compliance and safety. You will foster and maintain collaborative relationships with external agencies, suppliers and stakeholders related to quality/performance initiatives. You live the INSTI Core Values through and through and play a vital role in driving forward our mission to get people tested with the best technology on the market.
INSTI’S CORE VALUES:
- INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes initiative on projects.
- NEVER SAY NEVER: Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
- SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
- TAKES OWNERSHIP of goals, decisions, actions and results: Arrives on time and prepared, leads by example, follows through on commitments.
- INSPIRED to excel: Demonstrates passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings and the business.
HOW YOU WILL CONTRIBUTE:
You’ll work closely with Executive Management, Manufacturing Operations, Sales and Marketing and Scientific Affairs to support bioLytical’s daily operations and develop long range strategies consistent with corporate objectives.
Responsibilities related to Quality Control:
- Provide leadership, guidance and direction to QC personnel consistent with statutory and regulatory requirements and bioLytical’s Quality Management System (QMS).
- Provide leadership and guidance for laboratory improvement projects and troubleshooting of testing methods in collaboration with Product Support as appropriate.
- Responsible for improving product quality, minimizing costs and maintaining effective laboratory systems and processes to ensure integrity of all testing results.
Responsibilities related to Quality Assurance:
- Mentor and lead the Quality Assurance team and oversee the planning and implementation, monitoring and improvement of the Quality Management System (QMS).
- Participate as a bioLytical’s representative during third party audits and inspections by regulatory agencies. Oversee supplier evaluations, internal audit programs and second party audits.
- Leading continuous improvement effort for both the Quality System and business systems as applicable.
- Responsible for supporting manufacturing with the implementation of quality tools to streamline processes and cut costs.
- Provide guidance on quality assurance for product development and manufacturing optimization projects.
- Lead the company activities in compliance with US FDA, Health Canada, European Union, Australia, Brazil (Medical Device Single Audit Program), World Health Organization and other Rest-of-the-World countries’ quality system requirements.
Responsibilities related to Regulatory Affairs:
- Mentor and lead the Regulatory Affairs team in review and preparation of complex submissions to US FDA, EU Notified Body, Health Canada, WHO, TGA, ANVISA and all other regulatory submissions to concerned International Regulatory Authorities.
- Responsible for overseeing regulatory assessments for all document, product, and process changes to ensure that change notifications to regulatory bodies are appropriately submitted and approved.
- Responsible for overseeing regulatory assessments for non-conformance reports, product/process deviations, corrective and preventive action reports, out-of-specification reports, and so on.
- Oversee timely medical device adverse event reporting and complaint handling in accordance with governing regulations along with post-market surveillance activities.
- Responsible for decisions related to designing, reviewing and approving Product Support internal studies and clinical evaluations. Responsible for providing regulatory input related to each device development phase during new product developments.
- Develop long term strategic plan for Quality Assurance, Quality Control and Regulatory Affairs departments
- Develop and implement key quality and regulatory metrics and report on same at executive management meetings
- Maintain good working relationships by interacting proactively and persuasively with global regulatory agencies to gain approvals.
- Stay up-to-date with changing quality and regulatory requirements for US FDA, Health Canada, European CE marking, World Health Organization, Australia Therapeutic Goods Administration, Brazil ANVISA and Rest-of-the-World (as applicable). Actively review new regulatory requirements to maintain proficiency in worldwide regulations and communicate pertinent information.
- Develop and manage the budget and staffing requirements (including specialized regulatory consultants) for the quality and regulatory departments.
- Recruit, mentor and provide performance management for all quality and regulatory personnel.
- Responsible for addressing training and development requirements for new hires and existing employees in the quality and regulatory departments.
WHAT YOU BRING:
- Masters or Bachelors degree in a scientific or engineering discipline, or equivalent combination of education and experience
- A minimum of 20 years work experience in medical device/In-vitro diagnostic device/engineering manufacturing industry with 10 of those years managing people and 5 at the executive level
- In-depth knowledge of Canadian, US and European regulations, ISO 13485, MDSAP and ISO 14971
- Regulatory Affairs Certification preferred
- Six Sigma knowledge would be ideal
- Ability to set and drive a strategic vision
- Strong organization, managerial and people management skills
- Ability to craft persuasive regulatory arguments
- Superior analytical, problem solving and reviewing skills
- Must be able to deliver results on schedule in a fast-paced, dynamic environment
- Excellent prioritization, organizational and project management skills
- Effective communication – speaking, writing, teaching/mentoring and presenting
WHAT WE OFFER:
- A competitive compensation package
- Reimbursement of travel expenses to candidates shortlisted for in-person interviews
- Relocation costs for successful candidate not residing in Vancouver, BC area
- Extended health benefits including medical, dental, optometry, RMT, etc.
- Flexible working hours
- Bonus day off with pay on your birthday every year!
- Paid sick days
- Complimentary reserved parking
- Complimentary shuttle to/from the office and River Rock Hotel/Bridgeport Skytrain Station
- Exercise room with a gym and shower facilities
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- Oh and you will also have a chance to show off your dance moves and singing voice at the holiday parties, lead in lawn bowling or volleyball at the summer barbecues and devour cake at the monthly birthday celebrations
HOW TO APPLY:
bioLytical Laboratories Inc. offers a challenging, enriching work environment and competitive compensation commensurate with experience. For additional details about this opportunity and to apply, please send a cover letter, resume and salary expectations to firstname.lastname@example.org.
We are an equal opportunity employer and invite applications from all qualified individuals.