Site Quality Head, NASD

Job Description

The Site Quality Head of NASD (Nucleic Acid Solutions Division) is responsible for providing quality and regulatory oversight to the NASD division of the Diagnostics & Genomics Group (DGG) in Agilent Technologies.  The leader is accountable for all quality and regulatory decisions and outcomes impacting this division and partners with matrixed teams in DGG BIOVECTRA GQRA and Agilent GQRA.  The Site Quality Head, NASD will report to Quality Head, NASD & BIOVECTRA, with a dotted line to NASD General Manager.

This position will ensure quality, and regulatory strategies are established, provide input to NASD business strategies, support projects and business objectives, and oversee the execution of quality and regulatory in accordance with global regulations and standards.  This position guides products from early phase/pre-toxicology material through potentially commercial finished drug product.  The leader will partner closely with the BIOVECTRA GQRA leader to ensure alignment of common processes and procedures.  The leader will serve as a member on the business leadership teams in NASD.   The new leader must have strong leadership capabilities to build close business partner relationships and lead teams through change.

This leader oversees the development, implementation and maintenance of Quality systems and activities for NASD, including Quality Assurance, Quality Control, Document Control, and QA Validation. Coordinates interdepartmental activities such as budgeting, managing direct reports, hiring, and administering performance reviews.  Involved in customer interactions concerning Quality.  The Site Quality Head, NASD can act as a delegate for any Quality position.

The position requires extensive cross-functional interaction throughout the Agilent organization, strong liaison activities with the Agilent site management teams, Agilent senior management, as well as with external notified bodies and third parties including FDA, PMDA, and other global regulatory authorities.  This position is in Boulder and Frederick Colorado.

KEY RESPONSIBILITIES

• Develops and continually improves the strategy for policies and procedures, ensuring compliance with regulatory agency and client requirements.

• Oversees and directs NASD activities to meet US and international pharmaceutical regulatory requirements. 

• Represents Quality & Regulatory as part of the NASD management team, with the NASD Quality & Regulatory forum and with the Agilent Quality & Regulatory partners.

• Oversees and directs customer quality and regulatory interactions such as visits, audits, and providing responses and materials to customers.  Representing Quality Assurance in Agilent internally and externally (FDA, regulatory authorities, customers and third parties).

• Directs their leaders in the development and implementation of GMP compliant quality systems for NASD. 

• Leads the NASD team through the execution of the business integration strategy for DGG. 

• Directs the quality assurance and quality control at NASD.  This includes Product Release, Supplier Quality, Quality Engineering, Quality Systems, Document Control, Internal Audit, continuous improvement and Training.

• Ensures the development and implementation of GMP compliant quality control programs for NASD.

• Oversees, directs and manages the Product Quality Engineering leader in the development and implementation of the site Product Quality Engineer and QA teams.

• This team represents NASD Quality & Regulatory in the implementation of Client Quality Agreements, and other client interfacing activities, and QA review/approval of validation program, SOPs, and protocols/reports.

• Directs the development and implementation of GMP compliant training programs for NASD.

• Establish quality objectives, key performance indicators (KPIs) and action plans within global Quality and Regulatory to ensure compliance to all global regulations.

• Identify, assess, and manage quality risks or compliance concerns proactively and take immediate corrective action as required.

• Deviation handling (NCR/CAPA/Deviations), Verification/Validation efforts, Quality Control/ Product Release and associated Quality Reporting: Assuring a responsive organizational quality culture and customer focused team responsive to customer needs, regulatory compliance, and business operation needs.

• Ensure a robust supplier and external manufacturer oversight process and procedures is established that meets business and regulatory expectations.

• Stays abreast of global regulations and guidance applicable to products defined in the NASD business strategies and influences new quality and r