Director Quality Audits # 4413

Responsibilities:

• Interface with individuals at all levels of the organization to conduct audits at specified intervals and report audit findings, facilitate and monitor the life-cycle of audit findings until completion, promote continuous improvement of systems, products, and services, establish and maintain QMS systems that are in conformance with international and local requirements.
• Develop, manage and execute inspection readiness programs across the GRAIL QMS to ensure site readiness at all times, including inspection logistic and management preparation and execution and subject matter expert training, development and coaching.  Facilitate Mock inspections as required to ensure a state of readiness. 
• Manage and support the external regulatory compliance inspections (CAP, NYSDOH, FDA, IVDR), responses, and action implementation follow up, support internal audits by acting as an auditor or driving completion of audit actions when required and analyze and monitor quality data to identify potential high risks and implement necessary actions to mitigate compliance and product risk.
• Provide guidance to assist in the development, implementation, and maintenance of the Quality Management Systems to ensure the organization functions effectively and efficiently in order to ensure a high level of Regulatory Compliance and to achieve Company goals, objectives, and policies as well as satisfy customer requirements.
• Develops and provides inspection execution related training in support of compliance systems and quality improvements.
• Partners with various internal and external groups to help analyze problems, identify and communicate options, and recommend appropriate solutions. Disseminates audit findings to senior management as required by the Corporate Quality System Audit Program.
• Develops and creates audit reports, coordinates action plans, and follow-up with auditee to assure prompt and adequate completion of agreed upon actions.
• Establishes and conducts sectional readiness training for GRAIL functions Serves as GMP subject matter expert (SME) for regulatory inspections, as needed.
• Leads contracted 3rd party audit activities used for supporting the Corporate Quality System Audit Program.
• Responsible for technical development of personnel, leading others through audits and ensuring the quality of deliverables within their purview. Supports corporate functions with expertise and assistance as they undergo 3rd party investigations is also required.
• Establishes/maintains effective cross-functional team communications to advance quality activities.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Directly responsible for ongoing maintenance and continuous improvement of this audit program. Assists with inspection activities (preparation, conduct, and responses) for Quality System inspections required by the Corporate Quality Systems Audit Program, which includes auditing company manufacturing sites and corporate quality system functions encompassed at various GRAIL facilities.
• Coaches/mentors staff as a means to ensure performance and professional development.
• Helps development and reporting of quality and compliance metrics related to Compliance audit activities.
• Hiring, managing, developing, retaining, coaching and mentoring staff including setting individual and team goals and conducting performance reviews.

Preferred Qualifications:

• BA/BS and10+ years in Quality Assurance.
• Minimum of 10  years of GMP auditing work experience in the medical device, pharmaceutical, or biotech industry.
• Experience in medical devices, manufacturing IVD, clinical diagnostic, CAP/CLIA or similar experience is preferred.
• Extensive knowledge of good manufacturing, strong understanding of FDA, ICH and IVDR regulations and Quality Systems; Solid background in Quality Assurance/ Systems.
• Outstanding auditing skills and attention to detail with audit program implementation including interpreting regulations, guidelines, and identification of compliance issues.
• Demonstrated broad expertise related to the principles and application of quality and regulatory compliance.
• Displays highly developed organizational leadership qualities and effective coaching abilities.
• Listening, interpreting, and summarizing information skills must be highly developedExcellent communication and writing skills; Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
• Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.