External Manufacturing Quality and Compliance Lead

Job Descriptionn n Johnson & Johnson Consumer Products Company, a member of Johnson & Johnson’s Family of Companies, is recruiting for an External Manufacturing Quality and Compliance Lead.n nJohnson & 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.n nThe External Manufacturing Quality and Compliance Lead will provide overall Quality Assurance leadership in the management of contract manufacturing sites while ensuring a high standard of quality assurance and compliance.n nThe External Manufacturing Quality and Compliance Lead is responsible for complying with processes and controls ensuring that the performance and quality of the new and existing portfolio of products conform to established standards, J&J policies and procedures, U.S.

and Global Quality System Regulations (QSRs) including 21 CFR 210 & 211, 21 CFR 820 and 21 CFR Part 11 and current Good Manufacturing Practices.

This individual will also ensure that cross-functional partners understand our quality system requirements and how they impact product quality and regulatory compliance.n n Responsibilitiesn Subject Matter Expert (SME) for quality assurance processes, procedures, audits (internal and external), and activities.

Develop and deliver training on QA-related topics.

Remain current on assigned quality system training and seek out training and knowledge in adjacent areas.

A mentor to junior staff.

Provide the QA review and approval on change control documentation from initiation through implementation and closure.

Provide detailed or summary communication to QA and cross-functional management 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 a QA lead resource for a CAPA or investigation.

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.

Quality systems responsibilities include quality manual, document management, and change control, ensuring that all products manufactured under the manufacturing network meet the product requirements.

Independently represent Quality Assurance function on multiple, simultaneous, high-impact/high-value projects as the “Voice of Quality”, including active team engagement, proactively ensuring that quality and compliance inputs are integrated into 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 that 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.

Provide project leadership or participates as a team member on major initiatives that have high impact to the business.n Educationn n Qualificationsn A minimum of a Bachelor’s Degree (BA/BS) is required.

A focused degree in Engineering, Chemistry, Biology, or Biological Sciences is preferred.n Experiencen A minimum of six (6) years of GMP experience in Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production is required Working knowledge of cGMP, cGLP and GDPs and experience with managing under an FDA regulatory environment is required Demonstrated ability to collaborate with internal/external partners to enhance relationships and interactions, including interfacing with senior levels of management to inform, drive change, and provide direct feedback is required Proficiency in MS Word, Excel, and Power Point applications is required Strong technical writing skills are required Requires excellent prioritization, communication, and leadership skills Demonstrated ability to accomplish work goals, with minimal amount of daily direction and oversight is requiredn Knowledge, Skills And Abilitiesn Proven ability to lead and influence others within product teams with excellent communication and presentation skills is required Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries and influencing without authority is required Detail-oriented, with the ability to work in a fast paced environment with multiple, concurrent priorities many needing immediate resolution is required Strong communication (verbal & written) and interpersonal skills, self-awareness and adaptability is requiredn Othern Individual must be willing and able to work in Ohio for the first 6-9 months in the role May require up to 75% of domestic and international travel.n 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.n n