Quality Assurance Manager in Skillman, New Jersey | DiversityInc Careers
 
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Quality Assurance Manager


Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting a Quality Assurance Manager to be located in Skillman, New Jersey.


Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.


The Quality Assurance Manager will serve as Quality site lead for NA products manufactured by affiliate sites at J&J Brazil/Sao Jose dos Campos, J&J China/Shanghai and others.


In this role, you will provide management of J&J Consumer Trade Customization sites engaged in the assembly and distribution of products for Vogue, Neostata and other business units and support the supplier quality management program for Business Quality.


Responsibilities include, but are not limited to:

  • Provide leadership in development of an annual GMP audit schedule for External Manufacturing assembly sites and testing laboratories and plan execution of these Audits to the schedule for all managed sites
  • Coordinate management of audit reports, gain senior management alignment for audit rating and so that audit reports are published in a timely manner. Drive closure of MAPs, through holistic and comprehensive engagement and negotiation with EM.
  • Provide Quality Metrics such as: Quality Holds, NCs, CAPAs
  • Site management review for affiliates (J&J Brazil and J&J China etc)
  • Support product-related change controls (FAIs and impact assessments), NCs, CAPAs, Quality Holds for affiliates (J&J Brazil and J&J China) and Vogue & Neostata businesses
  • Support Design Control process for NA products at these affiliates as applicable
  • Subject Matter Expert (SME) for quality assurance processes, procedures, and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas. And be a mentor to junior staff.
  • Provide detailed or summary communication to senior cross-functional leadership on status of key initiatives and issues.
  • Document rationales which are technically accurate and regulatory compliance focused for product disposition, risk assessment/mitigation, non-conformances, corrective actions, and audit observation responses. Hold business partners accountable for delivering documentation of similar quality.
  • Conduct, execute and document thorough investigations and CAPAs for high risk/high complexity issues. Ensure timeliness of deliverables through independent, proactive intervention. May act as a CAPA owner or be assigned as QA lead resource for a CAPA
  • Troubleshoot high risk/high complexity quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes.
  • Design and implement quality and compliance improvement programs and initiatives. Innovate solutions to significant quality system gaps and lead continuous improvement projects.
  • Represent NA Source Quality on multiple, simultaneous, high-impact/ high-value projects as the “Voice of Quality”, including active team engagement, proactively ensuring quality and compliance inputs are integrated into the project objectives, and act as a QA “go-to” resource for cross-functional business partners.
  • Independently manage and prioritize highly complex and diverse workload ensuring deliverables are on-time, accurate, and meet their intended objective.
  • Independent decision-making authority and accountability for product disposition and compliance decisions with significant potential impact to customer service
  • Review and approve compliance records, specifications, new product introduction development plans, procedures, and other documents, as required by procedure.
  • Leads the development and introduction of new processes and procedures which may impact multiple functions or regions. Brings forward innovative process improvements to drive compliance and/or efficiency.

Qualifications
  • A minimum of a Bachelor's degree is required.
  • A focused degree in Engineering, Chemistry, Biology, or Biological Sciences is preferred.
  • An advance degree (Master’s / MBA) is preferred
  • A minimum of 10 years of GMP experience is required.
  • Experience in Pharmaceutical, Medical Device, OTC Drug and or Cosmetic production environment is required.
  • Detailed working knowledge of cGMP requirements and current FDA enforcement issues required.
  • Demonstrated ability to lead cross-functional teams and collaborate with internal/external partners is required.
  • Excellent analytical, prioritization, communication, and leadership skills are required.
  • Experience in facilitation of internal and external audits and regulatory inspections is required
  • Demonstrated working knowledge of root cause analysis techniques including but not limited to: brainstorming, data collection and analysis tools, 5-whys, Fishbone (cause and effect), FMEA, and DMAIC is required.
  • Ability to work independently with minimal supervision is preferred.
  • Process Excellence/Six Sigma Certifications, ASQ Certified Quality Engineer and/or ASQ Certified Quality Auditor certification is preferred.
  • This position is located out of Skillman, NJ and may require up to 20% domestic and international travel including nights and weekends.

Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.


Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.



Primary Location
United States-New Jersey-Skillman
Organization
J & J Consumer Inc. (6101)
Job Function
Quality Assurance
Requisition ID
2017180522