Director, Process and Cleaning Validation Lifecycle

1 week ago

Toronto, Ontario, Canada ValGenesis Full time

ValGenesis Inc. is seeking a strategic and seasoned Director of Product to oversee our Process and Cleaning Validation lifecycle solutions. As an integral leader within our organization, you will spearhead the product strategy, development, and execution, ensuring alignment with our overarching business goals. This role requires a deep understanding of Process Validation stages and regulation standards in the Life Sciences and Pharma Manufacturing industry.

You will act as a subject matter expert, driving innovation and operational excellence in a fast-paced, dynamic environment.

Desired locations:
In office - Toronto, Canada; Santa Clara, California. Remote - Dublin, Ireland; Boston, Massachusetts; Raleigh-Durham, North Carolina; Munich, Germany remote.

Responsibilities:

  • Subject-matter Expertise: Provide insights from your deep understanding of industry regulation standards (GMP, FDA 21 CFR Part 11, ICH Q7, EU GMP, ISO standards, GxP, and GAMP 5), combined with expertise in cleaning validation principles and process validation stages to support informed decision-making, provide leadership and Product Development and Improvement.
  • Strategic Leadership: Define and execute a comprehensive product strategy focusing on outcomes over outputs, aligning product development with business objectives and customer success.
  • Lifecycle Management: Oversee the entire product lifecycle, from ideation through development, launch, and continuous improvement, focusing on cleaning, and process, validation.
  • Cross-functional Collaboration: Lead and collaborate with cross-functional teams including R&D, Engineering, Sales, Marketing, and Support to deliver products that meet the strategic needs of the business.
  • Customer and Market Insights: Deeply understand market needs through customer engagement, competitive analysis, and market research. Translate insights into actionable product initiatives that drive competitive advantage.
  • Outcome-driven Execution: Focus on delivering key outcomes by setting clear goals and metrics, monitoring progress, and adapting strategies as needed to meet changing market and business demands.
  • Team Development: Build, mentor, and lead a high-performing product management team, fostering an environment of growth and continuous learning.
Requirements
  • 10+ years of combined experience in product management, project management, or technical consulting within the pharmaceutical or related industries, with a proven track record of successful employee management.
  • Strong leadership skills with the ability to influence without authority and drive cross-functional teams towards outcomes.
  • Robust analytical and strategic thinking skills, capable of understanding complex product challenges and crafting clear, outcome-driven solutions.
  • Proven experience in fostering innovations that align with the rigorous demands of the pharma manufacturing sector
  • Demonstrated experience and willingness to represent the company at industry conferences, including delivering presentations and participating in panels to enhance our visibility and thought leadership within the pharmaceutical industry.
Preferred:
  • Masters-level University Degree or Ph.D. in Chemistry, Pharmaceutical Sciences, Biochemistry, Biotechnology or Microbiology
  • Advanced understanding of Pharma Manufacturing processes and regulations.
  • Prior experience with Cleaning and/or Process validation technologies.
  • Experience or understanding of Risk management (ICH Q9) and CPV programs
  • Relevant Product Management certifications such as Pragmatic Marketing, Scrum Master, or Scrum Product Owner.
  • Willingness to travel globally (up to 15%).
We're on a Mission

In 2005, we disrupted the life sciences industry by introducing the world's first digital validation lifecycle management system. ValGenesis VLMS revolutionized compliance-based corporate validation activities and has remained the industry standard.

Today, we continue to push the boundaries of innovation ― enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations.

The Team You'll Join
  • Our customers' success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity's quality of life, and we honor that mission.
  • We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done.
  • We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward.
  • We're in it to win it. We're on a path to becoming the number one intelligent validation platform in the market, and we won't settle for anything less than being a market leader.
How We Work

ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by loca
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