Compliance Area Specialist I

1 month ago

Forest Park, Georgia, United States Novo Nordisk Full time

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you'll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

Leading pay and annual performance bonus for all positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position Develop & maintain quality & compliance processes for assigned department. Ensure good execution & monitoring in accordance with regulations and Good Manufacturing Practice (GMP) requirements. Relationships Vice President / Director / Associate Manager. Essential FunctionsEnsure compliance with Regulations, ISO standards & corporate/local SOPsCoordinate tasks with QA & LoB to ensure compliance with company procedures, policies & objectivesDevelop metrics & analyze trends for Quality System process improvements, SPS, deviations, CAPA or laboratory investigationsWrite and/or review validation, deviations, change control, trend reports& other quality-related documentation for completeness & accuracyUtilize continuous improvement tools for Quality & Compliance operations to drive performanceProvide guidance regarding quality-related activities. Support users in the Quality Management SystemsSupport site-wide cross-functional investigations, systematic problem-solving & process improvementsInitiate & support compliance-related process confirmations & Go-Look-SeesResponsible to identify preventive actions to eliminate compliance gapsResponsible for managing inspection and audit coordination based on assigned area of responsibilityEstablish, monitor & process-confirm internal department compliance plans & self-audit/inspection readiness processesRepresent team in internal audits & inspections for general processes, compliance topics and coordination of requestsAdditional responsibilities specific to Production Support department rolesSupport project teams as a compliance resource, to include monitoring change management efforts & reporting project performance to the relevant stakeholders based on assigned area of responsibilityResponsible for execution & timely completion of quality-related return-to-service deliverables during site shutdown periods. Report performance to relevant stakeholdersFollow all safety & environmental requirements in the performance of dutiesOther accountabilities, as assigned Physical Requirements Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. QualificationsBachelor's degree in Life Sciences, Engineering or related field from an accredited university requiredMay consider an Associate's degree in Life Sciences, Engineering or related field from an accredited university with a minimum of five (5) years of pharmaceutical manufacturing, or other regulated industry experience requiredMay consider a High School diploma or equivalent with a minimum of seven (7) years of pharmaceutical manufacturing, or other regulated industry experience requiredMinimum of three (3) years of pharmaceutical manufacturing, or other regulated industry experience requiredGMP, QA and/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility preferredDemonstrated expertise in regulations & quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Validation, etc.) a plusAuditing experience a plusDemonstrated knowledge of NN processes & quality systems preferredDemonstrated experience leading process improvements preferredDemonstrated experience leading Kaizen and/or cross-functional process improvements a plusDemonstrated experience in training and coaching others preferredExpert knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in biopharmaceutical manufacturing a plusExcellent written & verbal communication skills preferredHigh level of proficiency in MS Office, MS Project, PowerPoint, etc preferredDemonstrated experience in solving problems & process improvements preferredHigh competency with regard to LEAN tools a plusDemonstrates excellence in time management, organizational & project management skills preferredBeing a role model for Quality Mindset by seeing/solving problems & sharing learning openly preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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