What are the responsibilities and job description for the Director Medical position at Orchestra BioMed?
About Orchestra BioMed
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies.
We accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies.
Our Business Model
We focus on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products we develop.
We are led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development.
Our Products
We have a pipeline of multiple late-stage clinical product candidates. Our flagship product candidates are:
- BackBeat CNT for the treatment of hypertension, the leading risk factor for death worldwide,
- Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide.
Director of Quality Responsibilities
The Director of Quality will proactively develop, lead and provide quality oversight for Orchestra Biomed including our Interventional Therapies programs.
This individual is responsible for managing the QA team to work collaboratively towards defining appropriate alignment with corporate objectives.
The successful candidate will work collaboratively with Regulatory affairs, product development, pharmaceutical development, clinical, and marketing, and across the organization to drive the evaluation of products and ensure the appropriate compliance with regulations.
Key Responsibilities
- Oversight of all quality-related activities for the development, testing, and manufacturing of medical devices and combination products.
- Ensuring compliance with global regulatory standards, fostering a culture of quality, and driving continuous improvement initiatives.
- Supervising and mentoring the quality team by mentoring staff, fostering collaboration across departments, and driving a quality-focused culture.
- Delegate appropriate levels of accountability for decision making across the quality team and clearly communicating requirements and plans, cross functionally within the organization.
- Developing quality strategies aligned with business objectives to ensure compliance, product integrity, and patient safety.
- Reporting on QMS performance metrics to senior leadership and recommending improvements.
Qualifications
Proven experience in device/pharma/combination products with at least 10 years of quality responsibility and at least 5 years in a leadership role managing a quality team.
BA/BS undergraduate degree in life sciences or engineering. Masters/PhD or other relevant advanced degree preferred.
Certified quality engineer, certified quality auditor) preferred.
Q8, Q9, and Q10), GxP, and other applicable regulatory compliance requirements required.
Experience implementing and managing quality/compliance systems and ensuring inspection readiness.
Experience in start-up environments and scaling/remediating quality systems for growing organizations a plus.
Demonstrated ability to lead and manage a high-performance team focused on accountability and exceeding expectations.
