Executive Director, Quality Systems & Operational Excellence

Location
Brisbane, California, United States
Posted
Aug 27, 2020
Ref
1270141373
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY:

Being a part of MyoKardia means you are a pioneer at heart, a go getter, a part of something meaningful. We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out
there. We roll up our sleeves and get to work on making things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what
makes the difference.

If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia.

The Head of Quality Systems & Operational Excellence will be responsible for the ongoi ng develop ment and iterative improvement of MyoKardia's GxP Quality System and core operational capabilities (document management, training, quality management, risk management , operational excellence) in line with projected company global growth and prep aration for first product commercialization. T his individual will have broad cross-functional interfaces to ensure that owned processes and systems continue to operate a s value-add service s across MyoKardia . This position will report to the Head of Quality and play a key leadership role within the Quality team and MyoKardia organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The successful candidate must have the ability to lead the development and implementation of programs that support the evolution o f practices and systems in a fast-paced, rapidly growing business . The candidate must possess exceptional interpersonal skills to establish productive cross-functional relationships, establish a "pull model" for services, and act as a catalyst/coach for co ntinuous improvement. Responsibilities include, but are not limited to:

  • Provide direction and oversight for the development and iterative improvement of MyoKardia's GxP Q uality System; ensure that global regulatory requirements and expectations are met a nd support the organization to be "inspection ready" at all times.
  • Serve as accountable owner and for Quality processes / systems that serve the business enterprise and/or broad cross-functional GxP activities:
    • Document management (Veeva QualityDocs)
    • Learni ng management (ComplianceWire) and GxP Training
    • Quality management (quality incidents/investigations, CAPA, technical change control, product complaint handling); including selection and deployment of an electronic system
  • Establish a maturity model/continu ous improvement approach, including stakeholder engagement models and use of strategic roadmaps, to efficiently and effectively evolve assigned processes / systems in conjunction with business growth.
  • Collaborate cross-functionally to establish appropriate s teering committees or advisory bodies to monitor use of Quality processes/systems and drive alignment in terminology and practices; ensure appropriate integrat ion with p rocesses / systems in adjacent areas (e.g. Manufacturing, Clinical , Legal, IT and HR Syst ems) .
  • Lead MyoKardia Quality Management Reviews. Collaborate with cross-functional leads and subject matter experts to identify/iterate key metrics , establish forums to drive business performance and ensure adherence to quality and compliance expectations.
  • Quality Risk Management: establish a program approach to build capabilities and processes for risk assessment, communication and mitigation. Ensure appropriate integration with other processes, e.g. enterprise risk management, project/portfolio management , and quality management review.
  • Operational Excellence: establish a program approach to embed the use of OE tools and practices as an integral way that work gets done within Quality (initial focus) and MyoKardia. C ollaborate with like-minded peers to esta blish a cross-functional community of practice to coordinate/prioritize activities and champion efficient and effective build out of processes/systems as company grows.
  • Computer Systems Validation/Data Integrity/Digital Health: establish staffing and suppo rt model to ensure quality and compliance oversight to IT, Manufacturing and Clinical; particularly to define phase appropriate expectations for integration of new technology platforms
  • Innovation: routinely scan external environment against internal future needs to proactively identify and implement innovative practices and technologies. Participate in relevant industry forums and work groups. Work with cross-functional peers to establish innovation as a learned skill within MyoKardia.
  • Play significant role during regulatory inspections as host, Subject Matter Expert (SME), front and/or back room support. Lead response development and action execution for assigned areas.
  • Lead establishment of Quality capacity planning and staffing models (contractors and int ernal employees) to support efficient and effective scaling of Quality support and services with the ongoing growth of MyoKardia .
  • Direct, develop and manage the Quality Systems & Op Ex function :
  • Ensure that a highly effective and motivated team is in place to meet the needs of the business
  • Perform people management and talent development activities
  • Serve as inspirational leader and role model across the MyoKardia organization
  • Maintain flexibility to p erform other functional or company-wide activities or pr ojects as assigned.


EDUCATION/EXPERIENCE/SKILLS:
  • Requires a Bachelor ' s Degree (or higher) in life sciences , engineering, or other related discipline
  • M inimum of twelve ( 12 ) years of experience working in the quality, clinical or manufacturing oversight r oles in the pharmaceutical, biopharmaceutical or medical device industries, in a global clinical and/or commercial environment
  • Strong working knowledge of global GxP regulations, requirements and guidelines (e.g. US, EU and ICH)
  • Excellent interpersonal ski lls, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders
  • Strong leadership and influencing skills ; proven ability to work effectively with cross-functional teams
  • Exper ience in establishing processes and associated systems, including ability to positively drive organization change management
  • Ability to apply sound judgement and decision-making skills (risk-based and phase appropriate)
  • Ability to deal with ambiguity; demo nstrated creative and pragmatic approach to problem solving
  • Strong working knowledge of Operational Excellence principles and tools; e.g. Effective Development of Organizations, Organizational Change Management, Visual Boards, SIPOC, Value Stream Mapping, Kaizen, Hoshin Kanri, Scrum, Agile, Lean Six Sigma, Maturity Models , Lessons Learned
  • Strong working knowledge of risk management tools and practices
  • Demonstrated ability to teach and coach on use of Op Ex and risk management tools
  • Experience with Veeva Qua lity Docs and ComplianceWire is a plus
  • Travel may be required


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