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Job Function:
Quality
Job Sub Function:
Multi-Family Quality
Job Category:
Professional
All Job Posting Locations:
Horsham, Pennsylvania, United States of America
Job Description:
We are searching for the best talent for Director, Product Quality Integrator to join our Quality organization located in Horsham, PA.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
Essential Job Duties and Responsibilities
- Hasend-to-endaccountabilityforthequality strategyand qualityaspects of new productsfromEarly Development through commercialization for an assignedportfolio of products.
- Develops and leads thequalityand regulatorystrategies tosupportnewplatformsthat are in- licensed or developedwithin theJanssenSupplyChain or other J&J operating companies.
- Developsand/ortranslatescreative and innovativecompliantapproaches to introducenewproductsthat are introducedright the firsttimeand result in first-passapproval.Helpsresolveissuesand facilitatesthetimelyadvancement of newproductsto ensure they arefiled and launched on time.Servesastheglobalresourcetothe entireQuality Organization to provideguidance,training, and consultation on newproductdevelopment. Serves as a consultant and mentor to colleaguesandmanagement
Main Duties / AdditionalDuties / Sphere ofAuthority
PrincipalDuties:
- Compliance with theGMP,EHS and SOXrequirements and guidelines, as applicable.
- RepresentsGlobalQuality on the CMC and Value Chain (VCT)Teams.Providesliaison betweenVCTand Analyticalgroup.Serves as the singlepoint of GlobalQualitycontactforan assignedgroup of products with high complexity.Establishes and developsstrongworking relationships with keystakeholders(withinJSC,R&D,and J&J) on a globalbasis.
- RepresentsPQM in a leadership role in variousmultidisciplinaryprojectteams,committeesandspecial projects as assigned.Providesoversight for thedevelopmentand maintenanceofspecificprogramsand/orprojects.Serves as champion for key projects.
- EnsuresQualitymilestonesand Qualitystagegatedeliverables are achieved. Qualityreviewer/approver of health authoritysubmissions(i.e., BLA, NDA, MAA)andassociated HA questions on thefilings.Approvesfilings and questions for secondaryfilings.Support PAI auditsfortheproductassigned.
- Accountable for readiness of stabilityprotocolsand reportsforNPIprocess validation and thecommitment protocolforprimaryfilings.LiaiseswithProductdataspecialists or Productqualityspecialists to gatherinput on stabilitytopics(e.g.draftstabilityprotocols and reports).
- Collaborates with a ProductQualitySpecialist on regulatoryquestions and on preparation of regulatory PA inspections.
- Haslinemanagement responsibilities(ifapplicable)leading a group of SeniorManagers or Managers. Is responsiblefor one or moreproducts(withhigh complexity)directly and for otherproducts(withlowercomplexity)through thedirectreports.
- May also haveresponsibility for ProductQualitySpecialists,whoarenotassigned to a specificproductand serve as a pooled resourceacrossDirectors’teams.Directorsupportsthereporting PQS and helpshim or herprioritizetasks/queries.
- Mentors within Product Quality and Quality Integrator sub-team.
- Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.
- Leads a comprehensive Quality new product integration team that ensures Quality throughout clinical, DS, DP, FF & device:
- Ensures product quality development through launch, understand the performance, and risk profile.
- Supports the sites, represents the sites on CMC and VC teams.
- Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
- Ensures standard Global Quality new product introduction processes and norms are current, used across sites and facilitates communication throughout Global Quality.
- Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
- Supports preparation of the criticality analysis per schedule.
- Ensures complaints are well managed, issues are understood, and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics.
- Partners with Quality Owner to complete Transfer of Ownership activities.
- API, RM, FP specifications approvals.
- Remains current in knowledge, skills and industry trends. Trains on new regulations, guidelines, procedures and processes. Makes a positive contribution by making suggestions for improvement.
- Maintains the flow of communications between Global Quality and the CMC and VC Teams. Represents Product Quality at CMC Council. Drives communication with all Q&C stakeholders.
- Support agency audits for the product assigned.
- Presents project updates to QM for Global Quality alignment in advance of Stage Gate.
- Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions.
Decisionmaking and ProblemSolving:
- Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
- Identifies and provides balanced management of quality and compliance risks with business needs.
- Gives input to the development of new strategies and implements and deploys strategies. Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total quality cost during commercial production. These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.
- Collaborates and support on the organization and transformation initiatives.
- Aware that quality decisions made at any time during the development of new products can be revisited years later during regulatory inspections and reviews.
- Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of high risk, uncertainty and ambiguity.
Innovation/Creativity:
- Expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs and more complex L&A deals, thus providing the best total value to the company.
Minimum Qualification
- A minimum of a Bachelor’s degree is required.
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
- Excellent computer proficiency e.g MS Office, SAP
- Excellent analytical skill to identify gaps and root causes of issues, and think out of the box to develop a solution.
- Must be able to work independently with minimum supervision to meet tight deadlines, and maintain a positive attitude.
If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), Creating Purpose, Internal Auditing, ISO 9001, Mentorship, Policy Development, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Management, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility