Director, Quality and Regulatory Affairs
This position is a key member of the Aziyo Biologics team and as such is involved in setting the Company’s short- term goals and objectives as it relates to quality and regulatory affairs.
This position will lead the quality assurance, quality control, and regulatory compliance teams for the Richmond site. The selected candidate will implement appropriate systems, policies and procedures to ensure quality and compliance and proactively develop improved processes.
In addition, this individual will play an integral role in coordinating activities across departments to achieve desired growth and established corporate goals in an entrepreneurial environment. For example, this leader will partner with operations to ensure compliance with applicable regulations.
Position reports to the EVP & GM, MSK Products
Essential Duties & Responsibilities
• Oversees the day-to-day activities related to the quality and safety of tissue products.
• Establishes and implements the quality systems to maintain compliance with applicable domestic cGTP and international regulatory requirements.
• Ensures non-conformances are investigated and CAPAs are implemented as required to maintain suitability of products.
• Ensures quality system audits are planned, performed, and necessary corrective and/or preventive actions are taken in accordance with established procedures.
• Develops, implements and verifies procedures for the inspection/ verification of products and services.
• Oversees the documentation system, change control, and ensures Good Documentation Practices are followed.
• Communicates the status of the quality system to management through the use of established metrics and reports.
• Oversees post market surveillance, including product complaints.
• Collaborates with manufacturing on product and manufacturing changes and ensures verification/validation activities are appropriately executed.
• Responsible for employee training system and tracking to meet operational, regulatory, and accreditation requirements.
• Leads continuous improvement activities.
• Assures compliance with the SOP Manual (SOPM) regulatory requirements and has responsibility and authority to approve or reject tissue, as well as discontinue processing and/or release of tissue when deviations from the SOPM warrants.
• Acts as liaison with appropriate local, national and international regulatory authorities, including FDA and AATB.
• Ensures compliance with all applicable federal, state, and local accreditation requirements, company policies and standard operating procedures.
• Oversees the review and approval of product and manufacturing quality controls and changes for adherence to quality system requirements.
• Prepares required regulatory submissions.
• Monitors regulations, standards, policies, and guidance issued by relevant regulatory authorities for changes that may impact the company and disseminates information accordingly.
• Oversees labeling and marketing materials for compliance.
BA or BS in the life sciences or a related degree program
Experience and Skills
• A minimum of 5 years in a management role with extensive quality experience in a FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred.
• Experience successfully interfacing with government and accreditation agencies (FDA, ISO, AATB), managing audits and writing regulatory filings, responses and other documents required in a regulated environment.
• Strong leadership skills; demonstrated ability to clearly develop and articulate short-term goals and objectives to drive performance and results
• Ability to juggle multiple tasks and prioritize work appropriately with a focus on timelines and deliverables
• Strong communication (written, oral and interpersonal) and presentation skills. Must have demonstrated experience presenting to diverse audiences including Internal (BOD, leadership team, employees) and external (Company executives, operations & purchasing teams)
• Excellent judgment and decision making capabilities; must be able to formulate business solutions to a myriad of challenges
• Ability to work collaboratively with various internal departments and leaders
• Ability to drive results through partnership, mutual respect and trust
Directly and indirectly manages 5+ employees in the Quality and Regulatory Affairs teams. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.