Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director Product Quality Leader- Biotherapeutics to be located onsite at a Janssen Large Molecule business location. Ideal locations include: Titusville, NJ; Raritan, NJ; Spring House, PA; Malvern, PA; Leiden, Netherlands; Cork, Ireland; Schaffhausen, Switzerland; Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.
The PQL serves as the Single Point of Contact to represent Global Quality and site Quality at the Compound Development Team (CDT), CMC Team, Clinical Team, New Product (NPT) and Value Chain (VCT) Teams. Establishes and develops strong working relationships within Therapeutic Area (TA), JSC (Janssen Supply Chain), DPDS (Discovery, Product Development & Supply) and J&J on a global basis. Accountable for the development and delivery of the quality and regulatory strategies for the lifecycle of the assigned Biotherapeutics product/program in partnership with the Quality colleagues across BioResearch Quality & Compliance (BRQC), PQM (Product Quality Management), JSC Quality, Business Quality (BQ), Regulatory Compliance and key business partners. Utilizes strategic thinking along with technical expertise to influence product/program strategies that are aligned with the quality strategies. Leads the creation of an integrated E2E quality plan, leveraging existing processes, governances and programs as applicable. PQL reviews/approves GMP documentation in lieu of Product Quality Integrator (PQI) and Product Quality Owner (PQO) where required.
• Works across BRQC, PQM, JSC Quality and BQ to develop aligned strategies covering key functional requirements. Leads, develops and implements processes to ensure compliance with global requirements for assigned products/program. Mentors associates within PQM and Quality sub-team members.
• Builds extensive quality context, and provides key inspection support and coordination during Health Authority and Mock inspections.
• Quality reviewer/approver of health authority submissions (i.e., BLA, NDA, MAA) and associated Health Authority questions on the filings.
• Leads Vertically Integrated Quality team members across BRQC, PQM, JSC-Q and BQ to assure Drug Substance, Drug Product, Filled Finished & Device are developed in according with Janssen GMP and GCP Standards. Product performance and risk profile are well understood.
• Collaborates with Quality management to make sure sufficient QA resources are assigned to support his/her assigned role for both Global Quality as well as local member.
• Assures Quality milestones and CMC Stage Gate/ RDCC Stage Gate deliverables are achieved. Represents Quality at CMC and RDCC Council. Drives communication with all Q&C partners.
• Ensures complaints are well managed, and issues are understood. Participates in product safety management teams to present Product Quality Complaints trends and topics.
• Escalates issues when appropriate. Works with the cross functional/site teams to co-ordinate and hold Escalation meetings, minutes archival, follow up on actions.
• Collaboration with BRQC members to establish quality monitoring plans for assigned product. This includes, but is not limited to, overseeing the performance of proactive quality monitoring and quality reviews; audit programs; providing GCP compliance support for J&J Pharma programs.
• Makes key decisions on behalf of Global Quality including sites. Identifies and provides balanced management of quality and compliance risks with business needs. Provide solutions to complex issues.Qualifications
• Minimum of Bachelor degree in a scientific discipline required; Advanced degree is preferred.
• Minimum 10 years of experience in drug development, quality, compliance or regulatory affairs in a regulated healthcare industry required.
• Strong scientific & technical capabilities required.
• Experience in more than one quality related discipline is preferred, including but not limited to, product development operations, regulatory filing, clinical studies, manufacturing operations and commercial distribution.
• Experience in Biotherapeutics/Large Molecule is required.
• Experience in a successful leadership role in building, inspiring and managing a large global team and influencing stakeholders across a matrixed organization structure preferred.
• Well-developed leadership skills, executive presence and the ability to influence others in a matrix environment required.
• Excellent communication and organization skills required.
• Solid presentation, written and oral communication skills as well as the ability to meet deadlines required.
• Strong attention to detail and analytical / problem-solving skills required.
• Business oriented, independent and driven required.
• Self-motivated with high integrity and a pioneering spirit required.
• Pro-active, creative, open, forward and strategic thinker capable of operational execution required.
• Strong conceptual and analytical orientation, as well as creative and unstructured problem-solving skills
• Able to evaluate problems and concepts from different perspectives; use data to identify key issues and opportunities and recommend sound and logical solutions.
• Strong results and customer focus orientation.
• Travel- Up to ~20% national and/or international travel as business needs arise.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location
United States-New Jersey-Titusville-Other Locations
Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Ireland-Cork-CorkOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function