Associate Director, Clinical Quality Assurance

Location
Brisbane, California, United States
Posted
Sep 29, 2020
Ref
1014206137
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

SUMMARY:

The Associate Director , Clinical Quality Assurance ( C QA) , will be responsible for providi ng GC P compliance oversight and support to MyoKardia's Clinical function s and clinical study teams. This individual will provide leadership, expertise and guidance regarding regulatory requirements, and GCP guidelines to ensure GCP compliance . Experience in qua lity support of Pharmacovigilance (PV) and knowledge of GVP is a plus.

MyoKardia's QA function is responsible for oversight of GCP, GLP , GVP, and GMP activities. This position will report to the Head of Clinical QA and be an integral part of the QA team . In this role, the individual will utilize a risk-b ased strategy to priori tize clinical QA/GCP support for clinical trial activities , identify and escalate compliance issues to enable proactive decision-making supporting GCP activities and support QA Sys tems activities, as necessary.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The successful candidate should be able to perform the following C QA responsibilities and activities. This includes but is not limited to:
  • Contribute and implement audit strategies a cross clinical program s
  • Perform CRO supplier risk assessments in support of QA Vendor Qualification program
  • Responsible for planning, conducting and/or overseeing the audit execution, reporting , and follow-up on MyoKardia studies in accordance with Good C linical Practice (GCP) , and lo cal and federal regulations for:
    • Vendors and C ontract service providers (Contract Research Organizations, central laboratories, core/specialty laboratories, etc.)
    • Clinical investigator sites
  • Conduct internal process audits fo r clinical functions
  • Establish quality agreements with CRO (s) managing clinical study activities, whe re necessary
  • Conduct reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, informed consents, investigator bro chur es, c linical s tudy r eports , etc. )
  • Represent C linical QA on clinical study teams
  • Direct operation and compliance activities with applicable stakeholders to establish timelines and accomplish tasks/projects
  • Support Inspection Readiness program and ins pections, and provide recommendations for its continuous improvement
  • Participate in the development and delivery GCP training , as needed
  • Develop, review, and implement SOPs relating to GCP, as needed
  • Initiate /P articipate in working groups and project tea ms regardi ng quality improvement programs
  • Stay abreast of changes in applicable FDA and European regulations, directive and guidelines and determine any impact on company studies
  • Must be capable and willing to travel (up to 15 %), including international t ravel
  • Maintain flexibility to perform other / additional tasks as assigned.


EDUCATION/EXPERIENCE/SKILLS:

Education:
  • BS/BA degree in a scientific field required; advanced degree is a plus
  • ASQ certification a plus


Experience:
  • Typically requires a mi nimum of 10 years in biotech/ pharmaceutical industry, with 5 + years of Clinical Quality Assurance ( pharmacovigilance/ GVP experience, a plus)
  • In-depth knowledge of and ability to interpret and apply GCP EU, FDA and ICH regulations and guidelines
  • Experience in planning and conducting GCP audits
  • Experience with regulatory inspections and inspection readiness
  • Experience with Quality Management Systems (e.g. documentation and records management, change control, deviations, investigations, training, and CAPA p rograms)
  • Experience reviewing and auditing study-related processes and documentation
  • Experience in the use of relevant computer systems used in clinical and non-clinical research including safety databases
  • Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders
  • Excellent oral and written communications skills
  • Excellent organizational skills, with ability to successfully manage multiple priori ties
  • Strong influencing skills: proven ability to get things done
  • Ability to work effectively and collaboratively with cross-functional teams