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 regulatory policy as the science and technology advances.

Serves on business leadership teams, working with other functional leads on strategic planning, headcount, and financial management for the NASD, representing quality and regulatory.

Team Management: Provide expertise, guidance, and training to the organization within area of responsibility. Be the role model in driving and supporting the continuous improvement effort. Responsible for team development, identification of the competence and profile needed, including recruitment.  Mentor managers and establish a pipeline of new leaders across the organization.

Travel is required 10% of time.

Responsible for scheduling, directing, hiring, training, compensating, making administrative decisions, completing performance appraisals, and coaching of two or more subordinate managers/employees.  Must exercise full discretion in terms of costs, methods, and employees.

Qualifications

Master’s degree or equivalent in biology or related life sciences field; or more than 8 years related experience and/or training; or equivalent combination of education and experience. Prior experience and/or training working in a GMP production environment is required.

Minimum 8 years working in an FDA regulated industry and experience interfacing with regulatory bodies.  Prior experience working in a GMP production environment is required.

Strong experience with regulatory inspections in a GMP environment, as lead representative is required.

Experience with national and international regulatory registrations, submission, regulations, and developing effective relationships with regulatory agencies.

Expert knowledge of cGMP regulations and guidance documents a pertaining to the production of APIs, drug products and applicable GLP testing.

Technical knowledge/experience in:  oligonucleotides, enzymes, sterile fill, cleaning validation, and related API pharmaceutical requirements with ability to communicate these technologies with internal scientists and customers.

Technical knowledge/experience in the following areas would be an asset: chemical synthesis/complex chemistries, high potency products, cell and gene therapy, product conjugation and ligation with ability to communicate these technologies with internal scientists and customers.

Ability to read and interpret analytical data as it pertains to the operations performed.

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.  Ability to deal with nonverbal symbolism (formulas, scientific equations, and graphs) in its most difficult phases.  Ability to deal with a variety of abstract and concrete variables. 

Lean, Six Sigma training and/or certification an asset.

Minimum of 8 years management experience leading managers, including hiring/recruiting, performance management and manager development activities.

Strong leadership skills and ability to motivate and lead teams through change.

Proven ability to drive cultural change across an organization, working in a cross-functional environment to influence and build consensus among teams.

Demonstrated track record of results using interpersonal, relationship-building skills required to lead multi-cultural and geographically dispersed teams in a fast-paced, highly matrixed environment.

Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the Internet.

Skill in communication, written and verbal; will be handling various relations issues and will be confronted with various interactions. Ability to respond to common inquiries or complaints from customers, co-workers, subordinates, and supervisors regarding the products and processes.

Skill in managing and sponsoring various projects; must be able to use individual discretion in completing work assignments; while assisting the group in establishing priorities, setting standards and working collectively to accomplish deadlines and objectives.

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Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least November 13, 2024 or until the job is no longer posted.

The full-time equivalent pay range for this position is $175,440.00 - $274,125.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required: 10% of the Time

Shift: Day

Duration: No End Date

Job Function: Quality/Regulatory