Program Lead, Quality Planning & Strategy - Pharmaceuticals

PROGRAM LEAD, QUALITY PLANNING & STRATEGY/LEIDEN, NETHERLANDS/10 MONTHS CONTRACT/UP TO 72 EUR PER HR

MAIN RESPONSIBILITIES WILL INCLUDE:

Develop and manage integrated quality plans (IQPs) to support business-critical activities (such as health authority submissions to support new molecular entities or new indications for use)

Work with risk owners across R&D functions to develop effective risk mitigation plans to control risks identified in the IQP

Provide input to trial oversight and quality strategies to ensure that issues are identified in the IQP and mitigated early, and that predefined risk mitigation plans in the IQP are executed in a timely fashion and are effective in mitigating the risk to an acceptable level.

May execute quality oversight activities as per IQP plan.

Lead quality working groups (QWGs) to define and refine the IQP. Organize and lead meetings of the QWG to periodically assess quality metrics to determine if risks are adequately defined and controlled under the IQP. Communicate outcomes of QWG meetings to relevant stakeholders, including senior management.

Lead or assist in the early identification, escalation, and resolution of significant quality issues pose a significant risk to achievement of core company objectives.

In collaboration with Regulatory Compliance, lead inspection readiness activities to support health authority submissions. Develop and execute pre-inspection readiness activities for internal Janssen R&D and external parties that contribute to regulatory submissions.

May Manage Site Inspections as well as Sponsor Monitor Inspections outside the three major inspectorates (FDA, EMA, MHRA). Support inspections managed by Regulatory Compliance.

Leverage quality analytics data and contextualize key quality insights to primary stakeholders and provide quality consultancy. Consult/Collaborate with other BRQC functions to harness the single point of contact model to our business partners

May Manage the utilization of BRQC resources in the IQP. Ensures that BRQC activities are integrated to maximize BRQC support of submission readiness.

Consults with appropriate business partners and peers within BRQC to provide guidance or review and approve Corrective and Preventative Action Plans (Self Identified, Inspection) - may also develop Corrective and Preventative Action Plans.

Provides regular status reports to BioResearch Quality & Compliance (BRQC) management.

ADDITIONAL RESPONSIBILITIES INCLUDE:

Resolves compliance/regulatory issues with business leaders within the TA/DAS.

Lead cross-functional teams to determine risk level and make decisions about proper mitigation of risk to ensure submission success.

Participate/Lead in QP&S, cross-BRQC Janssen, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that support key activities.

Train/coaches others with regard to teamwork, interpretation of regulatory requirements, risk management and compliance activities

QUALIFICATIONS

A minimum of a Bachelor's degree is required. An advanced degree (MD, PhD, MSc, or PharmD) is preferred.

Experience in a Quality, Compliance, and/or R

Strong tracking, coordination and project planning skills;

Ability to identify and implement process and/or application improvements;

Strong analytical and problem-solving skills;

Must be able to work on multiple simultaneous tasks with limited supervision;

Quick learner, motivated self-starter;

Excellent customer service, interpersonal, communication and team collaboration skills;

Able to follow change management procedures and internal guidelines; Methodology/Certification requirements:

Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred;

Language proficiencies:

English spoken and written

THE COMPANY

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.