What are the responsibilities and job description for the Senior Quality Engineer position at Orchestra Life Sciences?
Senior Quality Engineer
Location : Philadelphia, PA
Industry : Pharmaceutical / Biotechnology (Cell Therapy Preferred)
Orchestra Life Sciences, a leading technical consultancy, provides strategic support and scientific expertise to accelerate the development of pharmaceutical therapies for cancer and rare diseases. Specializing in nuclear medicine, radiation oncology, cell and gene therapies, regenerative medicines, and biotechnology, we offer unparalleled expertise to help clients navigate the complexities of these advanced therapeutic areas. By collaborating closely with our clients, we aim to speed time to market, driving innovation and ensuring the success of cutting-edge medical solutions.
Job Summary :
We are seeking an experienced and dynamic leader to join our team as a Sr. QA Engineer . In this role, you will oversee the quality assurance and compliance for commercial manufacturing activities, ensuring the highest standards of quality in accordance with regulatory requirements for both the US and EU markets. The ideal candidate will bring a proven track record of leadership in the pharmaceutical / biotechnology industry, particularly within advanced therapies such as cell therapy.
Key Responsibilities :
- Lead and manage commercial QA efforts to ensure compliance with FDA , EU and GxP regulations , and guidelines in the advanced therapy space.
- Support quality functions for commercial manufacturing operations across the US and EU , ensuring all activities are aligned with regulatory requirements and best practices.
- Provide strategic leadership and direction for QA initiatives across commercial product lifecycles.
- Develop and maintain strong relationships with client, executives and other key stakeholders, fostering open, candid, and collaborative communication across teams.
- Drive continuous improvement initiatives to elevate the organization’s quality standards, processes, and compliance practices.
- Be a trusted advisor and liaison with regulatory agencies, ensuring proactive communication and management of inspections and audits.
- Provide guidance and leadership on strategic initiatives related to new product launches, commercial manufacturing changes, and regulatory inspections.
Qualifications :