Compliance Lead

About Johnson & Johnson

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.

Our treatments are smarter and less invasive, and our 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/ .

About the AMSC Team

The AMSC team is a critical part of the Global Analytical Development department in the Therapeutics Development and Supply (TDS) organization within Janssen R&D.

We focus on developing and validating innovative analytical methods to analyse and provide (non-) clinical release and manufacturing/characterization support for Drug Substances (DS) and Drug Products (DP) for small molecules and new modalities.

Additionally, we build up scientific understanding of the corresponding stability behaviours of the DS/DP to enable drug development.

Position Overview: Compliance Lead

We are looking for a Compliance Lead within AMSC who will play a pivotal role in ensuring the highest quality standards! The successful candidate will improve compliance across the portfolio, lead and supervise quality investigations, support inspections, and ensure all processes align with GMP regulations.

Key Responsibilities:


* Strengthen compliance throughout the portfolio by applying phase-appropriate GMP.


* Steer and coordinate Quality Investigations by identifying root causes, implementing corrective actions, and preventing recurrence.

Guide the team in writing investigations, documenting observations, and conducting risk assessments to ensure a transparent process.


* Support internal and external inspections by preparing documentation, guiding inspectors, and answering questions.


* Act as an SME for compliance-related topics, provide advice, stay updated with regulations, and share knowledge with the team.


* Partner with QA to guarantee all processes follow relevant GMP regulations, coordinating quality checks and implementing improvements.


* Represent the team in cross-functional quality workgroups.

Qualifications, Experience, and Skills:


* A Master's degree in Pharmaceutical, Chemistry, or any related sciences, with at least 4 years of relevant industry experience.

Alternatively, a Bachelor's degree in relevant fields with at least 6 years of proven experience.


* Expertise in cGMP regulations, ICH guidelines, policies, and standards.


* Strong leadership skills combined with the capability to conduct comprehensive investigations!


* Flexible and able to adapt quickly to constantly evolving business needs.


* Good written and verbal communication skills in English.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

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