Compliance Lead, Packaging & Technology

Biopharma Asia; Antwerpen; Ibrido; EUR 81.000 - 141.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Descrizione del lavoro

Johnson & Johnson Beerse, Antwerp, Belgium, is seeking a Compliance Lead for Packaging & Technology within the Clinical Supply Operations function. The role provides end-to-end compliance leadership across packaging, labeling, warehousing, and sample flows, ensuring robust ICH-GxP adherence and quality-system governance.

The candidate will translate regulatory requirements into practical actions, coordinate audits and inspections, and partner with QA, R&D, and operations to uphold operational

Competenze

• Bachelor’s degree in life sciences, engineering, pharmacy, quality, or related discipline.
• At least 6 years in clinical operations or a supporting function in regulated pharma environments.
• Strong ICH-GxP knowledge and familiarity with regulatory quality systems.
• Experience supporting deviations, investigations, CAPAs, audits, and inspections.
• Ability to work independently and influence without formal authority.

Mansioni

• Act as end-to-end compliance lead for packaging, labeling, warehousing and sample flows.
• Translate ICH-GxP and regulatory requirements into practical expectations for operations.
• Serve as primary P&T compliance contact for internal and external audits.
• Coordinate readiness activities for inspections and risk mitigation actions.
• Collaborate with QA, R&D, and operations to align compliance priorities.
• Monitor metrics and provide evidence-based compliance recommendations.
• Lead issue management, deviations, CAPAs and change controls with governance.
• Review procedures, work instructions, and training content for compliance.
• Support new product introductions with timely compliance input.
• Promote a strong quality culture and Credo Behaviors across teams.

Conoscenze

GxP knowledge

Quality systems

Risk management

Stakeholder engagement

Analytical skills

Regulatory compliance

Communication

Independent work

Formazione

Bachelor’s degree in life sciences or related field

Strumenti

Microsoft Office

Quality Management Systems

Descrizione del lavoro

At 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 .

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:

R&D Operations

Job Sub Function:

Clinical Supply Operations

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

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

We are searching for the best talent for Compliance Lead, Packaging & Technology.

Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position. Candidates authorized to work pursuant to a short-term status (e.g., F-1) who require future immigration sponsorship are not eligible.

Purpose: The Compliance Lead, Packaging & Technology (P&T), serves as the end-to-end compliance subject matter expert for the P&T organization. Reporting to the Logistics and Compliance Lead, the role provides compliance leadership and practical guidance across packaging processes and execution, labeling design processes and execution, local warehouse activities, and sample flows. This manager-level individual contributor partners with operational and functional stakeholders to maintain a state of control, ensure adherence to applicable GxP and quality-system requirements, and support reliable clinical supply. The role has no direct people-management responsibility.

You will be responsible for:

Act as the end-to-end compliance lead and subject matter expert for P&T, covering packaging processes and execution, labeling design processes and execution, local warehouse operations, and sample flows.

Translate applicable ICH-GxP, regulatory, quality-system, data-integrity, policy, and procedural requirements into clear, practical expectations for P&T operations.

Serve as the primary P&T compliance contact for internal and external audits and Health Authority inspections, coordinating readiness activities and supporting demonstration of end-to-end process integrity and compliance.

Coordinate inspection readiness across the assigned P&T scope, including preparation, evidence gathering, identification and escalation of key risks, response development, mitigation planning, and follow-up of commitments.

Liaise with QA, QS, business process owners, R&D Quality, and operational stakeholders to align compliance expectations, priorities, decisions, and actions across the end-to-end P&T organization.

Monitor and communicate compliance metrics, trends, and emerging risks; maintain fit-for-purpose compliance governance, routines, risk registers, and action tracking, and provide evidence-based recommendations to the Logistics and Compliance Lead.

Guide issue management for deviations, investigations, CAPAs, change controls, periodic reviews, and other quality-system processes, ensuring appropriate preventive and corrective actions are defined, tracked, and effectively implemented to uphold operational integrity.

Review and advise on procedures, work instructions, training content, specifications, and compliance controls associated with packaging, labeling, warehousing, and sample handling.

Support compliant introduction of new products, processes, systems, equipment, suppliers, and operating-model changes by providing timely compliance input and documenting requirements and decisions.

Participate as the P&T compliance representative in cross-functional operational workstreams and initiatives, providing risk-based guidance and supporting aligned implementation.

Support onboarding of new team members by providing role-relevant compliance orientation, training guidance, and access to applicable standards and procedures.

Promote a strong quality and compliance culture, employee engagement, inclusion, and adherence to Credo Behaviors by coaching stakeholders, reinforcing clear ownership, and serving as an accessible point of contact for compliance questions.

Build effective working relationships with P&T operations, Quality, Clinical Supply Chain, labeling functions, warehouse and sample-flow stakeholders, system owners, and relevant internal and external partners.

Qualifications/Requirements:

Minimum of a Bachelor’s degree in life sciences, engineering, pharmacy, quality, supply chain, business administration, or a related discipline, or an equivalent combination of education and relevant experience.

Minimum of 6 years of work experience in clinical operations or a direct supporting function within pharmaceutical operations, quality, packaging, labeling, warehousing, clinical supply, or another highly regulated environment.

Strong working knowledge of ICH-GxP principles, quality systems, data integrity, and regulatory expectations applicable to pharmaceutical packaging, labeling, warehouse activities, and sample flows.

Understanding of drug development and clinical supply processes and their interfaces with packaging, labeling, warehousing, and sample management.

Demonstrated experience supporting deviations, investigations, CAPAs, change controls, audits, inspections, and compliance-risk assessments.

Ability to work independently as a subject matter expert, influence without formal authority, manage multiple priorities, and make sound risk-based recommendations.

Strong analytical, relationship-building, stakeholder-engagement, written, and verbal communication skills, with the ability to collaborate effectively across organizational levels and functions.

Other requirements

Experience in clinical supply, pharmaceutical packaging and labeling, local warehouse activities, sample management, or related operational interfaces is preferred.Experience supporting GxP audits and Health Authority inspections and interacting with Quality or regulatory stakeholders is preferred.

Demonstrated ability to establish compliance governance, risk-management processes, action tracking, and meaningful compliance metrics.

Knowledge of the J&J Quality Management Systems is preferred.Proficiency with Microsoft Office and relevant quality, enterprise, packaging, labeling, warehouse, and reporting systems; experience using compliance metrics, data analytics, and visualization to identify and communicate compliance signals is preferred.

Fluent English, written and spoken; Dutch is preferred for effective collaboration with local operational and technical teams. Willingness to travel occasionally, up to 10%, as business needs require.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

€81,400.00 - €140,530.00

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.