SR Quality Excellence Manager PMO - 2406161697W

　　Description

　　Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Excellence Manager, PMO! This position will be located in Raritan, NJ or Malvern, PA.

　　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 (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal.

　　The Senior Quality Excellence Manager, PMO is an exempt level position with responsibilities for leading and providing quality oversight over a wide range of projects and activities within and beyond the internal & external vaccine, cell and gene therapy manufacturing facilities to support both clinical and commercial requirements. This role will help to establish and execute on the quality strategy, lead and support critical projects to improve cycle time, OOS reduction, capacity expansion, stability Q&C, and COGs improvement efforts.

　　Key Responsibilities:

　　Drive and coordinate the input for the long-range financial planning (LRFP) and yearly Business Planning (BP) processes, and identify specific needs for the AT network (QA and QC) considering future network demand. Ensure strong budgetary management, both CAPEX and OPEX, for QA and QC. Support deployment of a cost competitiveness focus and ensure the culture of continuous improvement is strong within the AT Quality network.

　　Engage closely with the Advanced Therapies leadership team and cross-functional stakeholders to deliver strategic solutions, engage as a thought partner, and drive Quality initiatives. Deliver updates and recommendations to the LT on progress, risks and actions required to attain objectives. Develop, maintain and execute Advanced Therapies Quality projects that forward our strategies to maximize productivity, reduce OOS, improve quality, reduce turnaround time, improve costs, and optimize QA & QC processes across the platform.

　　Maintain visibility across key projects and programs; support the LT in overall management, prioritization, risk monitoring, and course corrections as required; assist and/or lead in specific projects, as needed.

　　Support identification, roadmap, sequencing and delivery of Continuous Improvement / Competitiveness Projects throughout QA and QC in partnership with the network Site Quality Heads and Lab leads. Support implementation of a strong Project Management discipline and focus to execute on Quality projects.

　　Partner effectively with Site Quality Heads, above site Quality teams and JJRC to facilitate deployment of network wide quality improvement / competitiveness initiatives.

　　Represent ATSC Quality Platform in the development, planning and execution of corporate initiatives.

　　Support the implementation and maintenance of the Advanced Therapies Quality Management Review (QMR) for the platform; ensure that AT sites provide the necessary data, information and updates for an effective QMR.

　　Develop and implement the department’s strategic communications initiatives to foster alignment against our objectives, engagement and inspiration including communications campaigns, staff meetings, open sessions, Town Hall meetings; develop content for communications; ensure communications are meeting department needs; measure effectiveness and relevance.

　　Coordinate regular Leadership Team and department meetings by developing agendas, recording decisions and action items in each meeting, documenting, and following up on action items between meetings.

　　Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

　　Require minimal direction to complete tasks, know how to get resources and information from established internal contacts; consult with supervisor for decisions outside of established processes.

　　Other duties may be assigned, as necessary.

　　Qualifications

　　Education:

　　A minimum of a Bachelor’s Degree is required with a focus in engineering, science, business, or equivalent discipline is required.Experience and Skills:

　　Required:

　　A minimum of eight (8) years of experience in Quality Assurance and/or Operations related to manufacturing

　　Knowledge of cGMP regulations and FDA/EU guidances

　　Experience working with Quality Systems

　　Knowledge of the business environment inside a Quality organization across various roles

　　Strong leadership capabilities, in particular as a change agent, and ability to lead transformation projects to deliver higher performance

　　Strong track record in delivering business improvements projects

　　Business acumen; previous experience with budget and capacity planning (OPEX, CAPEX, headcount)

　　Proven track record working in and supporting a global matrix environment

　　Ability to translate strategy to execution and drive the organization forward in executing and delivering results

　　Strong organizational, conflict management and decision-making skills

　　Ability to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile and rapidly changing environment

　　Strong negotiation and interpersonal skills; ability to communicate across all levels of the organization

　　Excellent organizational skills across multiple work streams/disciplines with the ability to plan and anticipate deadlines and deliverables while coordinating with various members team to close out tasks/projects

　　Understands when to escalate issues and escalates issues appropriately and respectfully

　　Strong written and verbal communication skills

　　Fluent verbal and written English communication skills; other language skills advantageous

　　Preferred :

　　Experience in Process Excellence (Design Excellence, Six Sigma)

　　Experience in Biologics or Cell/Gene therapy

　　Experience working in an aseptic manufacturing facility

　　Knowledge of Good Tissue Practice and experience with vaccine or cell/gene-based manufacturing/testing

　　Lean Six Sigma or other Process Excellence Certification

　　Working knowledge of quality system applications such as TrackWise and truVault

　　Other:

　　This position may require up to 10% of domestic and international travel.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 NA-US-New Jersey-Raritan

　　Other Locations NA-US-Pennsylvania-Malvern

　　Organization Janssen Pharmaceutica N.V. (7555)

　　Travel Yes, 10 % of the Time

　　Job Function Multi-Family Quality

　　Req ID: 2406161697W