Innovative Medicine Transcend (ERP) Program Quality Leader

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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Digital Quality

Job Category:

People Leader

All Job Posting Locations:

Beerse, Antwerp, Belgium, Ringaskiddy, Cork, Ireland

Job Description:

About Innovative Medicine

Our 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.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

NJ, USA - Requisition Number: R-028802

Zug, Switzerland - Requisition Number: R-030888

Beerse, Belgium and Cork, Ireland - Requisition Number: R-030890

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for IM Transcend (ERP) Program Quality Leader role.

Purpose: The IM Transcend Program Quality Leader will be a part of the IM Transcend LT. IM Transcend is a multi-year global business transformation initiative that will modernize our end-to-end business digital capabilities by harmonizing our disparate ERP ecosystem, standardizing our core business processes and products [across Commercial, R&D, Plan, Source, Make, Quality, Deliver, and Data], and enabling our integrated data strategy through a single SAP S/4 HANA instance.

Quality standards that need to be followed within technology programs originate from a variety of sources: regulators, internal quality standards, internal policies, product standards, procedural norms, etc.

The Program Quality Leader applies the specifications of the corporate and organizational Quality Systems and Quality Standards to ensure that the quality of processes and deliverables of programs continuously meet their specified corporate and regulatory requirements. In addition, the Program Quality Leader will be involved in the assessment of potential external partners and in the evaluation and tracking of remedial activities of such partners.

The PQL may be called up to manage Quality-oriented sub-tasks within a technology project, including but not necessarily limited to: supplier evaluation, validation, risk assessment, risk mitigation, audit follow-ups, etc.

The leader will need to develop strong business partnerships across key stakeholder groups, including (but not limited to) the IM, Commercial, R&D, Quality, Regulatory, Enterprise Quality Central Finance program (CFIN), EPM, JJT, and Enterprise Sourcing.

You will be primarily responsible for:

• Refining and embedding the program Quality Management Framework.
• Driving quality execution throughout the program Methodlogy.
• Coorindating Program Documentation Deliverables and providing adherence oversight.
• Driving meaurable continuous quality improvements.
• Being the principle author of key quality-driven project deliverables (e.g. validation documentation functional risk assessments, etc.) in alignment with relevant compliance experts.
• Acting as a Program Quality “Advocate” with key stakeholders and as a Quality Consultant for the team.
• Collaborating and partnering with the Quality functions, providing advocacy and influence for the program’s approach to quality. Maintaining an active network with other quality managers and peers within compliance groups.

Qualifications / Requirements:

• Bachelor's/University or equivalent degree in Quality/Business/IT/Science or comparable experience.
• Minimum 15 years of progressive experience in leadership roles within Quality, and ideally also Supply Chain, or large transformation programs.
• Minimum of 10 years of progressive experience with GxP regulated processes in the pharmaceutical industry, preferably Quality Assurance, Supply Chain, Manufacturing or HSE (Health, Safety & Environment).
• Hands-on experience of applying Business Quality (GXP) in an ERP setting, preferably using Agile methodology.
• Required experience of applying SDLC principles in an ERP setting.
• Minimum 5 years of hands-on expeperience working in CSV IT Projects.
• Deep knowledge of IM Quality across all functions required.
• Demonstrated hands-on project management/delivery required. Experience in management of project timelines and milestones in complex business environments required.
• A highly respected expert in the Quality Function.
• Ability to effectively lead and govern cross-functional decision-making bodies required.
• Good Technical Writing and GDP (Good Documentation Practice) skills as the PQM has to author major validation documents like Validation Plans, Reports and other documents. Additionally, knowledge in deploying standardized work processes, tools, and templates required.
• Strong analytical, problem-solving, and critical thinking skills.
• Collaborative, able to shape and influence without direct line authority. Skilled at engaging and building relationships with senior business stakeholders required.
• Strong communication to create clear and concise messaging to leadership.
• Detail and solution oriented with ability to work within broad guidelines but challenge status quo.

OTHER:

• Requires proficiency in English (written and verbal) to communicate effectively and professionally.
• May require up to 30% of domestic and international travel.
• Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week.

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