Director, Quality Industry Best Practice CoE

DETAILS

Country:United States

Office Location:Hamilton, NJ (US HQ)

Experience Level:More than 9 years

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If you share a true passion for technology, enjoy working together in developing solutions, share ideas, and exchange knowledge we want to talk to you. Sparta Systems is the Leader in Enterprise Quality Management Solutions (EQMS) and moving forward!

Overview: Founded in 1994, Sparta Systems is the world’s premier provider of cloud and on-premise quality management software. The Company builds solutions, analytics, and expertise that speed up quality and compliance. Sparta’s solutions help to lower risk, increase efficiency, and keep consumers safe while allowing manufacturers, suppliers, and distributors to collaborate in a seamless and integrated environment. Sparta is privately owned and headquartered in Hamilton N.J, with offices across Europe and Asia. The company supports close to 1 million users across 700+ implementations, in more than 30 countries. Companies in life sciences, consumer products, discrete manufacturing and more, rely on Sparta. TrackWise, the flagship product of Sparta Systems, is the recognized market leader for Quality Management Systems. Particularly in life sciences and CPG markets, TrackWise addresses quality issues across post-manufacturing and in the field with technology and processes such as corrective action event tracking, supply chain tracing, regulatory compliance and resolution communication / documentation. The introduction of TrackWise Digital, Sparta’s SaaS and Cloud-based offering, has opened new market opportunities from both increased functionality and attractive price points. Built on the Salesforce.com platform, this product suite is moving the market from simply reactive to leveraging data for proactive operating efficiencies and reduced events in the field. Sparta is seeking a Director of its Industry Best Practice Center of Excellence (CoE) with deep knowledge and experience in the quality and regulatory life science industry including trends, potential disruptions and opportunities for expansion to ensure our customers’ current and future requirements are aligned and embedded within our product solutions, Industry Best Practice Templates, and our software implementation standards and methodologies. Position Summary: The Director of Quality Industry Best Practice CoE will occupy a critical position by understanding and establishing bi-lateral expectations during customer implementation, hybridization, and conversion of TrackWise and TrackWise Digital. This role will be the unifying force behind Sparta’s TrackWise and TrackWise Digital product implementations, combining feedback from Professional Services, Sales, Product Development, and our customers and prospects to deliver product capabilities and implementation standards and methodologies that satisfy current and future customer requirements.

Required skills:
The Person: 

  • Leverage life science industry quality and regulatory understanding in order to develop and drive the adoption of processes and methodologies for deployment of TrackWise and TrackWise Digital
  • Partner closely with Sparta’s Product teams to influence the near-term and long-term product and portfolio strategy for Sparta’s TrackWise Digital product suite to create sustained growth;
  • Create satisfied and referenceable customers to fuel Sparta’s future growth by assuring successful customer product implementations and accelerated time to value;
  • Interact with customers, engage in business case analysis and serve as an “ambassador” to functional groups, senior leaders across Sparta or external stakeholders.
  • Able to leverage past industry experience to credibly engage in direct dialog with prospective and current customers surrounding their needs and requirements for quality management systems
  • Possesses the organizational and industry gravitas to lead and influence cross functional teams to create alignment and drive change
  • Experienced in documenting and communicating standards, methodologies, processes, SOPs and/or playbooks; able to train and drive adoption of same across multiple roles and teams
  • Able to utilize customer and market input to influence product roadmap and implementation standards and methodologies
  • Development of strategic relationship with internal stakeholders, customers, and regulatory bodies
  • Must be able to work with limited supervision and be accountable for actions 
Required Skills:
  • Market Experience: a practitioner of Quality Management, deep knowledge of life sciences across clinical and commercial including leadership experience driving standards and methodologies
  • Domain Knowledge: Will have been in a life science manufacturing, quality and regulatory function within the last 5 years
  • Leadership: Proven ability to communicate crisply and influence cross-functional teams
  • Strategic Thinking: Ability to think strategically and communicate effectively with all levels of an organization, with the capability to guide, educate and influence the thinking of senior decision makers
  • Process Improvement:  Ability to streamline processes and drive efficiencies while improving business outcomes
  • Communication Skills: Excellent communication skills, is a strong negotiator and facilitator, and has excellent written and oral communication skills. Must be able to interface appropriately at all levels (i.e. engineers, management, executives)
  • Able to define the life science quality and regulatory value chain including trends, key players and potential disruptions

Preferred Skills:
  • Bachelor of Science degree; a combination of academic and work experience will be considered 
  • 8+ years’ experience in Quality Management in Life Science (pharma, biotech, meddev) industry with 3+ years’ in supervisory/ management roles.
  • Experienced and confident in developing and presenting recommendations to senior leadership
  • Familiar with 21 CFR Part 11, 210, 211, 315, 820, ICH guidelines, ISO 13485 and 14971, and other applicable regulation for the global life sciences industry.
  • MBA or post-graduate qualifications and professional memberships will be preferred
  • Background and experience in Six Sigma and/or Industrial Engineering preferred
  • Management / administration of Quality Management System preferred

Founded in 1994, Sparta Systems is the world’s premier provider of cloud and on-premise quality management software. We offer the solutions, analytics, and expertise that speed up quality and compliance. Companies in life sciences, consumer products, discrete manufacturing and more, rely on Sparta.

Sparta Systems Offers:
  • Competitive salaries
  • 401k and great benefits package
  • An outstanding collaborative work environment in our state of the art facility
  • Employee engagement programs such as Sparta Gives Back, Wellness, Spirit Committee, etc.
  • An opportunity to work for the world's premier provider of cloud and on-premise quality management software
Sparta Systems, Inc. is the industry leader for global enterprise quality management solutions (EQMS) and compliance management systems. Its TrackWise Enterprise Quality Management Software is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. We have an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle.

Life is short… Work somewhere outstanding… Sparta Systems!

Sparta Systems in an Equal Opportunity Employer with our Headquarters located in Hamilton, NJ

© 1995-2019 Sparta Systems, Inc. All Rights Reserved.
© 1995-2019 Sparta Systems, Inc. All Rights Reserved.Sparta Systems Logo