EPM Scientific are currently searching for a highly accomplished candidate to fill a vacancy as a Director for a Medical Device manufacturer based in Pennsylvania.
The Director of Quality Assurance will be responsible for the conceptualization, development, implementation/ deployment and improvement of current and future Quality Assurance and regulatory affairs functions. This person is the chief regulatory contact with all national and international regulatory authorities for any client or local concerns relating to the Manufacturing Operations. This position is also a chief client contact for development and manufacturing and associated quality activities in all matters relating to quality and regulatory compliance and is expected to participate in client negotiations and client interactions,
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Primary contact for all regulatory interactions with all domestic and world regulatory authorities, including EMA and FDA.
- Operate as the Head of QA for the Pennsylvania Quality Operations, with the final and authoritative word on all matters relating to quality, including lot rejection or acceptance.
- Implement necessary regulatory changes and updates to regulatory and compliance approaches.
- Oversee any training and Management briefings needed at any technical level required on updates and regulatory requirements for Medical Device manufacturing.
- Responsible for the conceptualization, deployment, implementation, maintenance, and continuous improvement of all Quality Management Systems (QMS).
- Lead and direct all Quality continuous improvement activities, including any remediation efforts to bring facilities, systems and processes up to current CRL standards.
- Provide necessary Quality oversight to all production, validation, supply chain and training functions
- Effectively model, demonstrate and live an employee-focused leadership style that prioritizes compliance, respectful and professional cross departmental collaboration, accountability, and the well-being, personal, and career development of each employee.
- Perform all other related duties as assigned.
Job Qualifications
- Minimum BS/BA Life Sciences or related field. An advanced degree in the life sciences is preferred, but not essential, based on experience
- Minimum 10 years of experience in a biologics, pharmaceutical, medical device, or related industry.
- Ability to maintain a high degree of accuracy and attention to detail.
- Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
- Demonstrated project management skills
- Demonstrated management and collaboration skills
- Outstanding verbal and written communication skills.
- Complete competency with electronic document managements systems and other information management systems
- Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.