AdresOperational Excellence Lead, Small Molecules - 2406175392W
Description
In this position you will provide strategic leadership and subject matter expertise within the External Quality team as well as to key internal and external partners to ensure the department consistently delivers pharmaceutical products that meet or exceed safety, regulatory compliance, and product standard. This role is responsible for the development and deployment of strategic initiatives, monitoring and driving key quality metrics, budget and resource management and will be a mix of hands-on leadership to support daily activities while utilizing a strategic mindset to ensure long term success.
Major Duties & Responsibilities
Provides the quality leadership and account manager support to ensure effective and compliant execution of quality systems. This may include executing procedural updates, gap assessments, HA updates, and APR
Monitor quality performance through the development of KPIs; extract performance indicating data and analyze data and author reports to identify risks and trends and drive implementation of mitigation plans
Develops strong collaboration with stakeholders to ensure translation of customer needs to fit-for-purpose
Acts as a decision support lead for the department’s leadership team in managing priorities and projects
Manage resource and budget management and project timelines, including long range forecasting and develops strategies with functional leader to meet volume or project increases.
Sets direction and drives a global team in defining and managing change, challenging the status quo, and problem solving to enable a long-term increase of productivity
Provides subject matter expert support for internal audits and regulatory inspections
Partner with key internal stakeholders in support of supply chain to meet patient supply requirements, including acting as a Single Point of Contact between External facing and Internal Facing Janssen Quality.
Describe important tasks or duties, not mentioned above, that are performed infrequently and are not critical to accomplishing the essential functions of the job
Qualifications
Bachelor’s Degree in engineering, science, or an equivalent technical discipline
Advanced Degree is a plus (MS, PhD)
A minimum of 8 years working in a regulated environment
A minimum of 4 years of experience with quality support of clinical or commercial manufacturing operations or closely related experience
Prior working knowledge/experience in the relative domain (Supplier/EM Quality, ECL)
Required Knowledge, Skills and Abilities:
Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production
Ability to effectively apply project management tools and lean methodologies when leading projects and programs is required. Knowledge of FPX is preferred.
Excellent leadership skills, self-starting/-motivated with highly developed interpersonal and teamwork skills
Ability to quickly process and communicate complex information and make critical decisions with limited information
Experience influencing or persuading others to accept new ideas, approaches or concepts or gains alignment on divergent issues with limited guidance.
Experience with External Quality processes and procedures
Understands and shapes strategic objectives of the External Quality organization and finds ways to implement these strategies in daily activities.
Helps others understand and apply organizational objectives.
Is viewed as a trusted partner across the business, anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances.
Exceptional creative and critical thinking, excellent decision-making and analytical abilities are required.
Big picture orientation with attention to detail and results oriented are required.
Ability to work in a matrix and multi-cultural environment required.
Proficient in written and spoken English is required.
Travel on the Job:
Yes, international
Percentage Travel
approx. 25%
Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Other Locations Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Geel, Europe/Middle East/Africa-Ireland-Cork-Cork
Organization Janssen Biologics (7266)
Job Function Quality Assurance
Req ID: 2406175392W
