head of quality assurance

overview:

The Head of Quality Assurance is the senior leader for the Quality Assurance Department for scPharmaceuticals, Inc. He/she establishes and maintains all elements of the Quality Management System to insure compliance with applicable FDA (US) and International Regulations and Standards required for scPharmaceuticals products. The position reports to the Senior Vice President of Technical Operations.

responsibilities:

  • Manage the development and implementation of the Quality System
  • Act as the Management Representative and Designated Representative
  • Ensure scPharmaceuticals and its CMOs are ready for
  • Identify key Quality System Performance Metrics and Objectives and provide guidance and leadership to your staff and the organization on how to achieve the Objectives
  • Advise, review and approve quality plans for drug product and device development, verification and validation, as well as manufacturing control
  • Supervise Quality Assurance team
  • Manage the internal audit system to ensure continued compliance to domestic and international regulatory regulations
  • Work closely with company Regulatory and Operations team to ensure local procedures and performance are consistent with company quality objectives
  • Manage the corrective and preventive system to ensure continued compliance to domestic and international regulatory regulations
  • Establish and coordinate the quality system training program to ensure that new personnel are trained to the cGMP and ISO requirements specific to their job responsibilities and that the existing personnel base is reviewed annually for additional training due to changes in the regulations and to foster continuous improvement
  • Audit and evaluate Suppliers on an ongoing basis, maintaining an approved supplier list

qualifications/skills:

  • Minimum of 15 years’ experience in a pharmaceutical environment and at least 10 years’ experience in a leadership position such as Quality Systems Manager/Director
  • Strong background in FDA 21 CFR Parts 210, 211 and 820; ISO 13485; European Medical Device Directive; and IEC 60601-1 preferred
  • Strong background in pharmaceutical quality assurance requirements from product development through manufacturing preferred
  • Experience as a Management Representative (per ISO 13485) preferred
  • Background with drug/device combination product regulations and procedures is a plus
  • Self-directed – able to work at all levels of the organization – “hands on” management to accomplish goals
  • Bachelor’s Degree (technical degree is a plus)
  • ¬†Assertive with appropriate humility, strong leadership and communication skills
  • Able to focus and effectively work under time restrictions
  • Ability to travel domestically and internationally up to twenty percent per month

scPharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.