Manager, External Quality job at reputed company in Holly Springs, NC

Title: Manager, External Quality Location: Holly Springs, NC. Hybrid Full time Job Description: At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, reputed company is responsible to our employees who work with us throughout the world. We reputed company an inclusive work environment where each person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional reputed company Job Posting Locations: Horsham, Pennsylvania, United States of America, reputed company Carolina (Any City), Raleigh, reputed company Carolina, United States We are searching for the best talent for a Manager, External Quality to be based in Holly Springs, NC. Purpose: In this position you will be responsible for providing quality leadership and reputed company of external manufacturers in the reputed company America region, ensuring consistent delivery of pharmaceutical drug substance that meets or exceeds safety, regulatory compliance, and product standards. The position works closely with External Manufacturing, Quality and Compliance functions, Internal J&J sites, Product Quality Management, and Global Manufacturing Science and Technology. You will be responsible for: Ensuring effective and compliant execution of quality systems at external manufacturing (EM) sites. Building relationships with reputed company partners with emphasis on Operational reputed company, Trust & Transparency, Agility & Resiliency, Partnership, and Innovation. Preparing EMs for successful health authority inspections; identifying regulatory compliance risks, and following up on associated commitments. Providing reputed company for technology transfer and new product introduction activities; leading PAI readiness and support associated health authority filings and approvals. Participating in the reputed company, qualification, and ongoing monitoring of external partners. Partnering with manufacturing sites and quality counterparts to identify and resolve quality issues and complaints, including development of robust CAPA plans and effectiveness checks. Reviewing and approving product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies. Contributing to process mapping of key quality systems to identify and implement innovative ways of working. Monitoring quality performance through tracking of key performance indicators. Partnering with key internal stakeholders in support of supply chain to meet patient supply requirements. Assessing reputed company quality systems and recommending improvements to improve compliance and optimize processes. Qualifications/Requirements: A minimum of a Bachelor's or equivalent University Degree is required with a focus in engineering, science, or an equivalent technical discipline preferred. A minimum of 8 years working in QA and/or QC functions in pharmaceutical industry. Experience in biotherapeutic manufacturing. Detailed knowledge of reputed company Good Manufacturing Practices reputed company to pharmaceutical production. Experience with manufacturing-facing support of clinical or reputed company manufacturing operations. Ability to work independently in support of a portfolio of products and suppliers. Ability to quickly process reputed company information and reputed company critical reputed company with limited information. Strong interpersonal, communication, influencing and leadership skills, demonstrating an ability to communicate at reputed company reputed company of the organization. Experience with cell culture, biotherapeutic drug substance manufacturing preferred. Experience working with external manufacturers preferred. Experience developing or reviewing electronic batch records preferred. Experience in development or application of digitally-integrated quality metrics preferred. This full time role is located in Holly Springs, reputed company Carolina. The position is remote-hybrid with an expectation of 3 days in-office at the manufacturing site in Holly Springs, reputed company Carolina and up to 2 days remote work per week. May require up to 10% domestic travel. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation Act. reputed company 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Alignment, Coaching, Collaborating, Compliance Management, reputed company Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility Apply tot his job Apply To this Job