Senior GCP Specialist

About Johnson & Johnson – Consumer Nordic
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in the Nordics are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity.
At Johnson & Johnson Consumer Nordic, we have a truly unrivalled brand portfolio, with power brands across multiple categories, including Neutrogena, Natusan, Piz Buin, o.b, Imodium, Ipren, Livostin and Nicorette. In Helsingborg we manufacture Nicorette and Rhinocort products for the global market. Our Nicorette products - found in over 80 countries - help people around the world to quit tobacco and live healthier lives. In addition to manufacturing, we also have a global research and development unit working in three areas: Smoking Cessation, Digestive Health and Cough & Cold. With around 650 employees we are one of the region's largest companies.



Objectives Of The Position

Johnson & Johnson Consumer Inc. is recruiting for a Senior Specialist, GCP Lead, to conduct GCP audits. The preferred locations are Sweden and Poland, however flexible arrangements for other European locations or remote working will be considered based on the candidate.

Our mission is to build QA of the Future by transforming the BioResearch Quality & Compliance (BRQC) audit function to be industry-leading and by delivering innovative ways to proactively secure compliance and drive sustainability and reliability across R&D.

Quality Assurance is responsible for the implementation and delivery of global cross-functional compliance audit programs to ensure that the development programs, Marketing Authorization Holders, functions, processes, and systems for Consumer (and all partners) are in compliance with company standards and Health Authority guidelines and regulations.

Responsibilities
Assess and assure GCP compliance with regulatory requirements and internal company procedures/processes.
Provide guidance and training related to GCP and the Consumer environment within the R&D Compliance group as required.
Participate in the execution of system audits aimed at evaluating and maintaining quality and compliance.
Participate in, plans, conducts, and prepare/issue audit reports for internal and external-vendor audits of, but not limited to, Trial Master File, Clinical Investigator Site, and document audits with little or no supervision.
Communicate with professional staff and leadership across departments on audit findings.
Facilitate CAPA responses. Tracks and reports quality issues/metrics to upper management. Drive process improvements.
Participate in corporate audits/regulatory authority inspections, project team meetings and training activities, as required.
Provide technical support to cross-functional teams and provide expertise and guidance to R&D colleagues/teams.
Provide guidance to the internal teams regarding GCP interpretations applicable to Consumer world as necessary.
Drafts, revises, and reviews departmental operating procedures (e.g., SOPs) and suggests process improvements.
Contributes to process improvements and development of new auditing procedures, techniques and departmental guidelines.
Process owner for select GCP R&D Compliance Standard Operating Procedures (SOPs).
Reviews and/or approves other departmental procedures from a GCP R&D Compliance perspective and provides supervisor with reports of compliance matters.
Collaborates on providing strategic direction for the R&D compliance group.


What You Will Need To Succeed
Efficient, organized and capable of prioritizing multiple tasks.
Experience working independently on projects and adaptable to changing priorities.
Excellent written and verbal communication and interpersonal relationship skills.
Flexibility to respond to changing business needs.
Strong networking and relationship-building skills.
Ability to plan and prioritize work in an efficient manner and work well under time constraints.




Qualifications
Minimum of 3 years of comprehensive GCP compliance experience (required).
Strong knowledge of GCP regulations and requirements as they apply to Drugs (Rx and OTC), Medical Devices and/or Consumer Sector Goods (required).
Experience with GxP auditing functions (required).
Experience with external vendor audits, Trial Master File audits, Clinical Investigator Site audits, document audits, and system audits (required).
Experience compiling and reporting compliance metrics (required).
Experience of the overall consumer product development process (required).
Technical knowledge with computerized systems (required).
Inspection support experience (FDA, EMA and other inspectorates) (preferred).
Ability to interpret global regulatory standards (preferred).
Proficient in English language (required).
Travel Up to 20% required primarily domestic EU (required).



Application
If you are interested in this position, please apply with an updated CV and Cover letter in English. The selection process will start during the 7-days posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.
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