Full Job Description
MyoKardia is seeking an experienced pharmaceutical quality and compliance leader to lead Quality Assurance and provide compliance expertise. The Vice President of Quality and Compliance will be responsible for all aspects of quality oversight from drug development through commercialization, including the manufacture of clinical products, the conduct of clinical trials, oversight of GLP and GCP CROs, and the manufacture of commercial products. The role will provide leadership and collaborate with all relevant functional areas to ensure compliance with applicable regulations and regulatory requirements. The role also requires an experienced compliance officer to lead the non-GxP global compliance function and ensure the operational effectiveness of the Company’s non-GxP compliance programs. Reporting to the General Counsel and Chief Compliance Officer, the individual will contribute to the development and implementation of organizational strategies, policies and practices, and work with senior management to integrate appropriate healthcare, corporate, privacy and other controls for MyoKardia’s global operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Play a leadership role in the conduct of facility and system audits at all relevant facilities, investigator sites, and vendors (including contract manufacturing and research organizations). Ensure audit results are communicated, findings are monitored, and any appropriate corrective actions are taken in a timely manner.
Support MyoKardia’s discovery, development and commercial-stage project teams, identifying key expectations of PTLs and team delegates, and facilitating dialog with development departments to optimize efficient decision-making and communication.
Optimize and build highly effective Quality and Compliance function. Coach, develop and retain talent.
Manage department budgets and timelines.
Support core project teams and lead sub-teams as well as develop members of their organization as core and sub-team members.
Identify and cultivate external advisors to further MyoKardia’s mission.
Serve as an external spokesperson for the company across a broad range of audiences: professional, regulatory, and corporate partners.
Oversee all aspects of Quality at MyoKardia, including:
Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, and compliance to applicable MyoKardia SOPs, GxP regulations and applicable country specific standards
Provide overall leadership for GxP compliance and establish comprehensive processes and systems that support cross-functional collaboration.
Oversee quality aspects of selection and management of CRO/CMO’s (contract research and manufacturing organizations):
GMP audits (with contract auditors where required)
Regularly assess evolving trends in quality assurance and implement state of the art practices
Develop training strategy and metrics to ensure all training programs meet GxP and ICH requirements and are appropriately tracked and documented
Lead efforts to ensure the organization is prepared for successful regulatory inspections.
Oversee the conduct of internal and external audits to ensure compliance with regulatory requirements for clinical trials and nonclinical studies and implement corrective actions to resolve audit findings
Develop proactive approaches to inspection readiness
Provide guidance on quality policies and SOPs for the organization
As a leader of the Compliance organization:
Develop, refine and update non-GxP policies, procedures and practices to facilitate global compliance and best practices for healthcare, corporate and privacy matters.
Develop and implement a global non-GxP training program, and oversee global training regarding healthcare, corporate and privacy matters.
Develop and implement a global non-GxP monitoring and auditing program and supervise audits and monitor the implementation of the Company’s non-GxP compliance operations.
Oversee the compliance hotline, investigate reports of noncompliance and enforce the Company’s Code of Business Conduct and Ethics and non-GxP policies, procedures and practices and recommend remedial action, corrective action plans and disciplinary action as necessary.
Develop a system for uniform responses to violations.
Conduct periodic risk assessments and develop and implement a work plan to address risk.
Prepare periodic Compliance activity reports and facilitate proactive communication and socialization of initiatives to ensure a culture of compliance at MyoKardia.
Report on a regular basis to senior management and the Board of Directors regarding compliance matters.
Build or maintain network of global compliance professionals and stay current on new laws, rules regulations, best practices and enforcement trends.
Other Projects when assigned
Education and Experience:
BS or advanced degree in chemistry, chemical engineering, other sciences, or related discipline with at least 20+ years of experience in drug discovery and development
Expert knowledge of quality principles and concepts. Reputation as a leader in the field with sustained performance and accomplishment
Good knowledge of advancing multiple molecules from development candidate nomination through NDA
Knowledge of global laws regarding kickbacks, fraud and abuse, false claims, drug development and marketing, price reporting, privacy, government contracting, bribery and corruption.
Extensive experience in Biotech/Pharmaceutical industry, advanced qualifications desirable
Strong working knowledge and interpretation of FDA/EU and ICH-GMP regulations and guidelines
Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
Experienced in all phases of drug development
Full understanding of CMC QMS and GMP regulations and expectations
Experience in auditing CROs/CMO’s and other entities which provide GMP contracted services
Capable of collaboratively engaging with external third parties to effectively execute the audit and inspection readiness strategy and approach
Able to apply a risk-based analysis to compliance issues and demonstrate creativity and flexibility in developing solutions that satisfy both business requirements and legal obligations.
Is viewed as in-house expert in quality assurance
Proven track record of translating vision to strategy design / implementation and execute effectively
Collaborate and communicate well with all levels of employees, including peers and cross-functionally
Familiarity with computerized systems and compliance requirements
Proven track record of leadership and management of quality and compliance
Able to mentor and guide teams on how to build strategies that optimize overall quality