ppAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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. /ppAs 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. /ph3Job Function /h3pQuality /ph3Job Sub Function /h3pQuality Assurance /ph3Job Category /h3pProfessional /ph3All Job Posting Locations /h3pBeerse, Antwerp, Belgium, Latina, Italy, Leiden, South Holland, Netherlands, Little Island, Cork, Ireland /ph3Job Description /h3pWe are searching for the best talent for a bProduct Quality Specialist. /b /ph3About Innovative Medicine /h3pOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. /ppJoin us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. /ppLearn more at /ph3Purpose /h3pThe Product Quality Specialist, Stability CoE, has end-to-end accountability for the stability management and oversight from Late Stage Development through full commercialization lifecycle for a portfolio of products. Responsibility for product quality related activities with a specific expertise in stability including protocol and report generation. Supporting the work of PQI/PQO and actively contributing to overall smooth functioning of the Stability CoE.

/ph3You Will Be Responsible For /h3ulliStability POC for a set of products families (API and Drug Product) /liliOversight of Sample management for stability /liliAuthor/oversight of stability Protocols and Reports in accordance with global SOPs including sampling strategy /liliSupport audits and filings as appropriate related to stability questions /liliResponsible for stability Lifecycle management /liliSupports PQI/PQO and Business Partners with stability related questions /liliSupport temperature excursions, change controls, stability notifications and escalations as applicable. /liliMaintain stability statements for assigned products. /liliPartner with Stability Labs as needed to ensure questions are addressed in a timely manner. /liliActive Member of Stability CoE: /liliSupport departmental goals. /liliGive input on topics raised in staff meetings to support continued improvement of stability processes. /li /ulh3Qualifications/Requirements /h3ulliBachelor’s degree with a major in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific degree is required. /liliA minimum of 6 years of relevant experience is required /liliA minimum of 4 years’ experience in the pharmaceutical, biotechnology, or medical device industry is required (post graduate experience and/or education will count towards years of industry experience). /liliExperience in API and drug product stability and business implications regarding stability decisions is desired. /liliUnderstanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management is required. /liliInsight in pharmaceutical and/or chemical processes, product quality assurance/control,

and product development and manufacturing is a plus. /liliDemonstrated ability to work independently and in a team environment /liliRelationship building as part of a team is required. /liliStrong written and oral communication skills with various levels of the organization. /liliUnderstanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with the ability to apply GMP regulations. /liliMust be flexible to accommodate US, EMEA and AP work schedules when vital, balancing work and personal time /liliThis position may require up to 5-10% domestic and international travel as business demands. /li /ulh3Required Skills /h3h3Preferred Skills /h3pBusiness Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards /ph3Benefits /h3h3The anticipated base pay range for this position is /h3pIn addition to base pay, we offer the following benefits*: an annual premio 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. /pulliThis is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change. /li /ul /p #J-18808-Ljbffr

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