Purpose:

The Associate Director of Quality Assurance is responsible for supporting Quality Executive Management in overseeing the quality management system for BioCreations Medical and ensuring that it is compliant with established procedures, FDA regulations, AATB Standards, and other applicable regulations, and industry standards.

Duties & Responsibilities:

• Support Quality Executive Management in defining and promoting a quality mindset throughout the organization.
• Support organizational strategic objectives.
• Develop, implement, and maintain procedures and controlled documents according to FDA, AATB, and other applicable regulations.
• Support Quality Executive Management in providing subject matter expertise to drive improvements and decisions relating to the quality management system.
• Oversee management of change control, the document change system, record control, and periodic review of controlled documents.
• Conduct quality review and approval of document/change orders for implementation.
• Lead training of new processes, process revisions, and corrective actions relating to quality.
• Oversee management and coordination of training requirements/assignments.
• Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections.
• Support Quality Executive Management in oversight and management of deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations.
• Ensure adequacy of investigations with respect to root cause analysis and CAPA assessment.
• Support Quality Executive Management in conducting quality review and approval for closure of deviations, nonconformances, complaints, CAPAs, SCARs.
• Lead risk management of department and ensure risks/issues are identified, addressed/reported, and where appropriate, escalated.
• Oversee and manage quality system related meetings including management review.
• Establish, evaluate, report, and provide improvements (where appropriate) for quality metrics.
• Collaborate with Product Management to establish/support product launch timelines.
• Support Quality Executive Management in providing quality oversight, support, and approval for new projects and products.
• Integrate shared leadership and foster collaboration across multi-disciplinary teams.
• Support development of equipment, process, and/or software qualifications, validations, and verifications.
• Support Quality Executive Management in review and approval of qualification, validation, and/or verification protocols, execution data, and summary assessments.
• Support Quality Executive Management in oversight and management of quality system software(s).
• Direct, participate, and/or support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures.
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP, and other organizations policies and procedures.
• Develop and maintain professional working relationships with current and potential customers, partners, and vendors.
• Manage direct reports.
• Establish and monitor objective annual goals for direct reports.
• Conduct performance reviews and establish performance improvement plans as needed.
• Establish and execute continuing education strategy for department.
• Attend/participate in offsite business meetings/conferences.
• Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments.
• Perform other related duties as assigned.

Skills & Abilities:

• Leadership
• Attention to detail.
• Organizational skills
• Critical thinking
• Effective verbal and written communication
• Ability to secure and maintain a favorable background investigation and clearance.

Education & Experience:

• Bachelor’s Degree in a biological science or related field required.
• At least 5-10 years of experience in quality for HCT/Ps and/or medical devices (or related industry), with progressive management responsibility/experience.