Agilent Technologies is excited to announce the formation of the Advanced Manufacturing Partnerships Division (AMPD), which brings together the Nucleic Acid Solutions Division (NASD) and BIOVECTRA Inc., A part of Agilent. This new division aims to align advanced manufacturing capabilities, expertise, and resources to foster greater innovation and operational excellence.
As part of AMPD, you will have the opportunity to work with cutting-edge technologies and collaborate with a team of dedicated professionals committed to making a significant impact in the industry. Join us in our mission to revolutionize advanced manufacturing and contribute to the success of NASD and BIOVECTRA.
At BIOVECTRA , we're passionate about advancing science and improving lives. As a leading manufacturer of active pharmaceutical ingredients and biochemical reagents, we pride ourselves on making a meaningful impact in the health and safety of our employees, our community, and our planet. We're looking for a proactive and visionary Associate Vice President, Quality at our biomanufacturing facility located in Prince Edward Island to join our team and lead the way in cultivating a safe, sustainable, and compliant work environment.
The Associate Vice President, BioVectra located at Charlottetown, PEI, Canada biomanufacturing center 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
20% of time.
Qualifications
KEY POSITION REQUIREMENTS:
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