Job Description

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. Orchestra BioMed’s vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed is led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Orchestra’s business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by its founding team. Its flagship product candidates are BackBeat CNT for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic for the development and global commercialization of BackBeat CNT for the treatment of hypertensive patients indicated for a pacemaker and strategic partnership with Terumo for the development and global commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.

Job Summary

At the direction of the SVP of Regulatory and Quality, the Director of Quality will proactively provide Quality oversight for Orchestra BioMed's Interventional Therapies business. The successful candidate will work collaboratively with Regulatory Affairs, Product Development, Pharmaceutical Development, Clinical, and Marketing, to drive quality related activities supporting the design, development, testing and manufacture of our products and ensure compliance with applicable regulations. This position also has responsibility for leading the, management and improvement of Corporate Quality Management System (QMS).

Leadership and Strategy:

• Supervise and drive 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 communicate requirements and plans, cross functionally within the organization.
• Develop quality strategies aligned with business objectives to ensure compliance, product integrity, and patient safety.
• Report on QMS performance metrics to senior leadership and recommend improvements.
• Management Representative of the organization responsible for yearly Management Review.

Quality Management System (QMS):

• Maintain and improve an effective QMS in compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable regulations.
• Oversee all aspects of the QMS including but not limited to document control, supplier management, training programs, CAPA systems, non-conformance handling and internal/external audits.
• Provide direction and oversight to manage events (e.g., deviations, vendor nonconformances) that may impact compliance status or create business risk.
• Ensure the QMS supports both device and drug components for combination products.

Regulatory Compliance:

• Ensure compliance with global regulatory requirements applicable to quality (e.g., FDA, ISO standards, EU MDR,).
• Act as the Management Representative for audits and inspections by regulatory bodies.
• Oversee clinical device deficiency handling and determine appropriate corrective actions as applicable.

Product Development/Design Control:

• Manage design control processes for new product development and sustaining engineering efforts, including integration and application of combination product related requirements.
• Ensure risk management activities (e.g., design/process FMEA) and design verification/validation (IQ/OQ/PQ) are conducted in a compliant manner.
• Ensure compliance with biocompatibility, sterilization validation, process validation, and analytical testing requirements.
• Ensure all phases from concept to product launch are conducted per applicable requirements.
• Ensure appropriate design and development plans are in place to delineate project scope and that resources are available to support on time execution of quality owned deliverables.
• Provide guidance on appropriate statistical techniques to utilize for sample size selection and/or data analysis.

Manufacturing Quality:

• Oversee quality control processes for incoming materials, in-process inspections, and final product release for product manufactured at vendors.
• Manage quality agreements with vendors to ensure adequate supplier controls in place with vendors to ensure compliance with applicable standards.
• Drive supplier qualification programs and monitor supplier performance.
• Drive or support product non-conformance investigations and ensure appropriate corrective actions are implemented.

Continuous Improvement:

• Implement initiatives to enhance process efficiency while maintaining compliance.
• Lead root cause analyses for non-conformances and implement corrective/preventive actions.

A current US work authorization is required in order to be employed by Orchestra BioMed . The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. The level of this position (Dir/Sr. Dir) will be determined based on the candidate’s final qualifications including skillset and years of experience.

Qualifications – Knowledge & Skills:

• 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.
• Applicable ASQ certifications (e.g., certified quality engineer, certified quality auditor) preferred.
• Extensive experience in ISO (i.e., ISO 13485 and ISO 14971), FDA (i.e., 21 CFR 820, 210/211, and Part 4), ICH (e.g., Q8, Q9, and Q10), GxP, and other applicable regulatory compliance requirements required. Extensive knowledge in product development (particularly for combination products) is strongly preferred.
• 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.
• Direct experience supporting quality aspects of regulatory filings (e.g., IDE/PMA/IND/NDA) and premarket approval inspections strongly preferred.
• Experience in strategic planning and collaboration with executives, key operational groups, cross-functional teams, and external partners.
• Proficiency in project management tools and methodologies to oversee multiple quality initiatives simultaneously.
• High level of personal and professional integrity and trustworthiness with strong work ethic.
• Excellent communication skills (written and verbal) and presentation skills.
• Extensive ability to analyze complex situations and propose practical solutions.
• Ability to develop and manage a high-performance team focused on accountability and exceeding expectations.
• Effective interpersonal skills including ability to lead, influence, and work within cross-functional team environments.
• Proven leader with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done.

Our Vision

To be a leader in bringing high impact medical innovations to life through risk-reward sharing partnerships.

Our Mission

We will work passionately to apply our collaboration-based business model to bring high-impact medical innovations to live and create extraordinary value for patients, care providers, partners and stakeholders.

Our Values

We care about patients, physicians, partners, and each other

We are creative , open-minded, adaptable and think “outside the box”

We are driven to always do our best and we do not give up

We deliver and are accountable to promised results

EQUAL OPPORTUNITY EMPLOYER

Orchestra BioMed is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

Important notice to employment businesses/agencies

Orchestra BioMed does not accept referrals from employment agencies unless written authorization from the Orchestra BioMed Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore Orchestra BioMed will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at Orchestra BioMed.

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