Head of Site Quality

Job Description

The Site Quality Head, BioVectra located at Charlottetown, PEI, Canada is responsible for providing quality and regulatory oversight. The Charlottetown, PEI facility is a CDMO (Contract Development and Manufacturing Organization) and report to the Advanced Manufacturing and Partnership Division (AMPD) of Agilent Technologies. The leader is accountable for all quality and regulatory decisions and outcomes. The leader will report directly to the Associate Vice President (AVP II) of Quality and Regulatory of AMPD. The Site Quality Head will lead an organization of >120 dedicated Quality staff in a highly dynamic environment supporting manufacturing, laboratory testing, client and regulatory inspections, and ensuring all products are following the latest guidance and regulations with a focus on patients and product safety. The facility operates multiple manufacturing facilities on premises and requires agility in application of regulations due to the diverse manufacturing capabilities that cover small and large molecules, sterile operations, and potent compound capabilities.

This position will ensure quality, and regulatory strategies are established, provide input to BioVectra 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 AVP of AMPD to ensure alignment of common processes and procedures. The leader will serve as a member on the Biovectra business leadership teams and will be a member of the AMPD Quality Leadership team. This position will be expected to lead the Charlottetown PEI site team through company integration and transformation, and as such, 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 activities and regulatory for BioVectra, including Quality Assurance, Quality Control, Quality Systems, Compliance, Internal Audit, Training, Quality Improvement and Regulatory. They will coordinate interdepartmental activities such as budgeting, headcount management, hiring, and administering performance and compensation processes. This leader serves as the point of contact for Quality and Regulatory for all customer interactions. The Site Quality Head, Biovectra will act as a delegate for any Quality/Regulatory position.

The position requires extensive cross-functional interaction throughout the Agilent organization, strong liaison activities with the Biovectra site management teams and with Agilent AMPD senior management. This position is the main point of contact for all regulatory authority interactions including Health Canada, FDA and other global regulatory authorities. This position must be routinely present at the Charlottetown, PEI, Canada facility.

Key Responsibilities

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

Oversee and direct BioVectra activities to meet US and international pharmaceutical regulatory requirements.

Represents Quality & Regulatory as part of the BioVectra management team

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).

Direct team leaders in the development and implementation of GMP compliant quality systems for BioVectra.

Lead the BioVectra team through continued Agilent integration.

Lead the BioVectra team through the execution of the business integration strategy for AMPD.

Direct the quality assurance, quality control and quality operations departments. This includes Product Release, Supplier Quality, Quality Engineering, Quality control testing, Quality Systems, Document Control, Internal Audit and Training.

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

Oversee implementation of Client Quality Agreements, and other client interfacing activities.

Direct the development and implementation of GMP compliant training programs and internal audit programs for BioVectra.

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.

Oversee deviation handling (NCR/CAPA/Deviations), Verification/Validation efforts, Quality Control/ Product Release and associated Quality Reporting

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

Stay abreast of global regulations and guidance applicable to products defined in the BioVectra business strategies and influences new quality and regulatory policy as the science and technology advances.

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

Team Management: Provide expertise, guidance, and training to the organization within area of responsibility.

Travel

Qualifications

EDUCATION:

• Master’s degree or equivalent in biology or related life sciences field; or more than 10 years related experience and/or training; or equivalent combination of education and experience. Prior experience and/or working in a GMP production environment is required.
  
  

EXPERIENCE:

• 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: Assays utilized for the testing of biologics and small molecule drug substances and drug products, biological laboratory management, and sterile and aseptic manufacturing. Ability to communicate these technologies with internal scientists and customers.
• Technical knowledge/experience in the following areas would be an asset: Sterile filling, mRNA, pDNA, LNP, microbial fermentation, aseptic manufacturing, biological assay development and testing, environmental monitoring/microbiology.
• 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.
• 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.
  
  

Additional Details

This job has a full time weekly schedule.

The full-time equivalent pay range for this position is $157,850.00 - $246,641.00/yr CAD 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 opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Travel Required:

Occasional

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory