At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Assurance **Job Category:** Professional **All Job Posting Locations:** Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America **Job Description:** Johnson & Johnson is currently recruiting for a 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. _At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity._ 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 team members to support organizational development **Qualifications** **Education:** A minimum of a Bachelor’s 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 8 years working in an FDA regulated environment + Experience in low bioburden or aseptic manufacturing + 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:** + This position may require up to 30% domestic & international travel. + This position has an estimated annual salary of $ $100,000- $173,500 USD$ + Employees and/or eligible dependents may be 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.- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).- Employees are eligible for the following time off benefits:- Vacation – up to 120 hours per calendar year- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year- Holiday pay, including Floating Holidays – up to 13 days per calendar year- Work, Personal and Family Time - up to 40 hours per calendar year 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com **The anticipated base pay range for this position is :** $100,000- $173,500 USD$ Additional Description for Pay Transparency: • This position has an estimated annual salary of $ $100,000- $173,500 USD$ • Employees and/or eligible dependents may be 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. - Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). - Employees are eligible for the following time off benefits: - Vacation – up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year - Holiday pay, including Floating Holidays – up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year