Sr Manager, Quality Document Management Lead

Location
Brisbane, California, United States
Posted
Oct 13, 2020
Ref
737242131
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 Document Management Lead will be responsible to further develop and iteratively improve the Quality Document Management program in line with projected company growth and preparation for first product commercialization. This individual will have broad cross-functional interfaces to ensure that document management processes and systems continue to operate as a value-add service across MyoKardia. This position will report to the Head of Quality Systems and Operational Excellence and be an integral part of the Quality team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The successful candidate should be able to perform the following responsibilities and activities. This includes but is not limited to:
  • Lead the execution and ongoing continuous improvement of the Quality Document Management program, including associated processes and electronic systems/tools
  • Serve as business owner and system administrator for Quality Document Management processes and tools (Veeva QualityDocs)
  • Collaborate cross-functionally to integrate and optimize processes and systems in adjacent areas (e.g. Learning Management System, Records Management, IT and HR Systems)
  • Represent Quality on cross-functional projects and teams; ensure leveraging of Quality Document Management capabilities and systems where appropriate.
  • Ensure that GxP requirements and expectations are met and incorporated into documentation processes and systems in support of first commercialization and ongoing phased development of pipeline products.
  • Accountable to monitor growth and needs for policies and procedures across the MyoKardia organization:
    • Maintain an index and functional mapping for documents in Veeva QualityDocs
    • Establish a cross-functional community of practice to collaborate across documentation development and associated training requirements
    • Develop tools and practices to assist MyoKardia to maintain and scale controlled documentation activities (e.g. establish templates, glossary/ies, look ahead calendars for periodic reviews, etc)
    • Ensure compliance with controlled document format and content
    • Review records to ensure they comply with good documentation practices
  • Lead the development and reporting of metrics for operational and quality management reviews to drive continuous improvement for assigned areas
  • Play significant role during regulatory inspections as Subject Matter Expert (SME), front and/or back room support; eg logistics, quality control and/or strategy
  • Carry out capacity planning (mix of contractors and internal employees over time) to ensure that services scale appropriately with the ongoing growth of MyoKardia
  • Recruit, retain and develop team members (over time, as applicable)
  • Perform other job duties as necessary, such as:
  • Develop and administer training for assigned areas (eg Veeva QualityDocs system use, good documentation practices)
  • Serve as back-up process and system administrator for other Quality System elements (eg LMS, QMS)
  • Participate in industry forums and working groups for assigned areas
  • Maintain flexibility to perform other and/or additional tasks as assigned.

EDUCATION/EXPERIENCE/SKILLS:
  • Requires a Bachelors Degree from an accredited institution preferably in sciences, plus a minimum of eight (8) years of experience working in the Quality related aspects of life sciences or closely related industry.
  • Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders
  • Excellent organizational skills, with ability to successfully manage multiple priorities
  • Strong influencing skills: proven ability to get things done and ability to work effectively with cross-functional teams
  • Strong understanding of GxP requirements
  • Demonstrated strong attention to detail, with ability to teach and coach others on importance of good documentation and datat practices
  • Proficient with WORD, EXCEL and other document applications
  • Must be able to work independently with minimum supervision
  • Experience with Veeva Quality Docs and ComplianceWire is a plus
  • Experience with Operational Excellence (belt or tool certifications; eg Greenbelt, Lean Six Sigma, Kaizen, EDO, Agile) is a plus