Senior Specialist External Quality

Job description

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: Professional All Job Posting Locations: Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Latina, Italy Job Description: J&J Innovative Medicine is recruiting for a Senior Specialist External Quality to be located in Latina (IT), Beerse (BE) or Allschwil (CH). This role will report to the Sr. Manager External Quality. External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners. In this role, you will play a crucial part in maintaining the highest quality and compliance standards for our Synthetic products, specifically focusing on Drug Products, produced at external manufacturing sites. You’ll collaborate closely with our External Quality Site Lead and be a champion for quality in everything we do! The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance. Essential Job Duties and Responsibilities This role supports business, quality and compliance objectives for externally manufactured Synthetic drug products, ensuring activities are performed in accordance with J&J policies, enterprise standards, quality agreements, cGMP requirements, ICH expectations and applicable regulatory commitments. The Senior Specialist EQ provides quality assurance support and oversight for external manufacturers and strategic partners involved in Synthetic drug substance and/or drug product manufacturing, packaging, testing, release, stability and supply activities, while helping to maintain product quality, compliance and reliable patient supply. Key Responsibilities: Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities. Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements. Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends. Identify, communicate and escalate quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans. Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes. Collaborate with External Quality Site Leads, Product Quality, MSAT, Planning, Procurement, Regulatory, EHS, Qualified Persons and external partners to ensure registered requirements and patient supply needs are met. Support external manufacturers during J&J audits, health authority inspections and regulatory commitments, including preparation, response review and follow-up of agreed actions. Participate in technology transfer, new product introduction, product lifecycle management, process improvement and risk management initiatives for Synthetic products. Contribute to continuous improvement of External Quality processes, documentation practices, quality culture and performance management across internal and external stakeholders. Minimum Qualification Minimum of a Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline. Minimum of 4 years of experience in quality management, quality assurance, production, quality control, R&D or a related pharmaceutical and/or biotechnology environment. Experience working in a GMP-regulated environment, preferably including quality support for external manufacturing, drug product or drug substance manufacturing, packaging, testing, release or commercial supply. Working knowledge of cGMP, ICH requirements, quality systems and applicable health authority expectations. Ability to review and assess quality records, identify gaps, support root cause analysis and contribute to effective CAPA and risk-based decision-making. Excellent verbal and written communication skills, including the ability to communicate effectively with internal functions and external partners. Ability to work independently with minimal supervision, manage multiple priorities, meet tight timelines and maintain a collaborative and professional approach. Excellent computer proficiency, including Microsoft Office and standard quality system tools. Experience with deviation, CAPA, change control, complaint, batch release, quality agreement, audit or inspection support processes. Preferred Qualification Experience working with external manufacturers, contract manufacturing organizations, external contract laboratories or strategic partners. Experience working on cross-functional project teams. Experience with product transfer, new product introduction, parenteral, and/or combination products. Other This role may require up to 25% of domestic & international travel. Required Skills: Quality Standards Preferred Skills: Communication, ISO 9001, Issue Escalation The anticipated base pay range for this position is: Benefits: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.