What are the responsibilities and job description for the Director Quality & Compliance (GMP) position at Boston Pharmaceuticals?
By leveraging a highly experienced drug development team, Boston Pharmaceuticals is building a portfolio of high value clinical candidates addressing important unmet medical needs.
Position Summary:
The Quality & Compliance Director (GMP) plays a critical role in participating in studies and programs and providing operational, compliance and system expertise for GMP and as a member of the Quality & Compliance organization.
Roles & Responsibilities:
• Assist and/or lead GMP quality efforts related to BP projects to ensure all development activities performed by BP staff, or on behalf of BP by Contract Service Providers (CSPs), are done with patient safety, data integrity and regulatory compliance in mind
• Lead and Network to maximize the use of external resources (CDMOs, CTLs, etc.) and integration with internal domain expertise.
• Responsible to ensure GMP compliance, governance and execution.
• Participate in CMC, study and program specific meetings.
• Organize and maintain GMP documentation and program files.
• Manage the GMP audit program, conduct qualification audits and investigations as necessary.
• Responsible for Quality program oversight, disposition, generation, review and approval of documents as appropriate.
• Collaborate and review functional SOPs for regulatory compliance
• Support regulatory inspections
• Trending and reporting of quality metrics and audit outcomes
Qualifications:
• BA/BS required, MA/MS or PhD preferred
• Minimum of 15 years in biotech/pharma/medical industry
• Experience with GMP Quality and Compliance operations, GCP/GLP/ GPVP are a plus
• Lead key initiatives, perform in dynamic complex environments and multiple changing priorities, with a keen attention to detail and discrete handling of confidential information.
• Strong communication, organizational and 360˚ influencing and motivation skills. Work collaboratively to achieve objectives and build successful partnerships.
• Active team participation and leadership skills, to achieve goals collaboratively and compliantly.
• Assess risk and translate data into knowledge and understanding and contribute ideas and concepts that impact success.
• Discern key findings succinctly, make well-founded recommendations, and imparts information and expert perspectives to senior management
• Focus on key priorities, assure patient safety and enable regulatory compliance by proactive, innovative, and independent thinking and action, at the speed of business.
