Senior Manager External Quality

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Horsham Pennsylvania United States of America Titusville New Jersey United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Manager External Quality! This position can be located at any J&J Internal Medicine site in the US with a preference for New Jersey or Pennsylvania.

In this position you will be responsible for providing quality leadership and oversight of external manufacturers in the North America region ensuring consistent delivery of pharmaceutical products that meet or exceed safety regulatory compliance and product standards.

Key Responsibilities:

• Ensure effective and compliant execution of quality systems at external manufacturing sites
• Participate in the selection qualification and ongoing monitoring of external partners
• Provide leadership in the identification and resolution of quality issues and complaints including facilitation of investigation process and development of robust CAPA plans
• Review and approve quality systems documentation including product disposition manufacturing instructions change controls specifications validation documentation and technical studies
• Monitor quality performance through the development of key performance indicators
• Lead the identification of risks along with the development and implementation of mitigation strategies
• Build relationships with internal and external partners; Influence external manufacturers to continuously improve processes and procedures focused on reliability execution and quality culture
• Collaborate with EMs to support health authority inspections; monitor and follow-up on associated commitments
• Provide oversight for technology transfer and new product introduction activities; lead PAI readiness and support associated health authority filings and approvals
• Partner with key internal stakeholders in support of supply chain to meet patient supply requirements
• Assess current quality systems and recommend improvements to improve compliance and optimize processes
• Provide mentoring coaching and training to direct reports or team members to support organizational development

Qualifications

Education:

A minimum of a Bachelors or equivalent University Degree is required with a focus in engineering science or an equivalent technical discipline preferred.

Experience and Skills:

Required:

• A minimum of 10 years working in an FDA regulated environment
• Experience in aseptic manufacturing of sterile injectables
• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production
• Experience with on-the-floor support of clinical or commercial manufacturing operations
• Ability to work independently in support of a portfolio of products and suppliers
• Ability to quickly process complex information and make critical decisions with limited information
• Strong interpersonal communication influencing and leadership skills demonstrating an ability to communicate at all levels of the organization.

Preferred:

• Experience working with external manufacturers

Other:

May require up to 30% domestic travel

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 . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Business Alignment Collaborating Compliance Management Fact-Based Decision Making Good Manufacturing Practices (GMP) ISO 9001 Mentorship Organizing Quality Auditing Quality Control (QC) Quality Management Systems (QMS) Quality Standards Quality Validation Regulatory Environment Standard Operating Procedure (SOP) Tactical Thinking Technical Credibility

The anticipated base pay range for this position is :

$122000-$209000 USD$

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire Employees are eligible for the following time off benefits: Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year Holiday pay including Floating Holidays 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year Parental Leave 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave 10 days Volunteer Leave 4 days Military Spouse Time-Off 80 hours Additional information can be found through the link below. Experience:

Senior Manager