Operational Excellence Lead, Small Molecules
il y a 2 semaines
- 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 fitforpurpose
- 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 longterm increase of productivity
- 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
- Excellent leadership skills, selfstarting/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.
- 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 decisionmaking and analytical abilities are required.
- Big picture orientation with attention to detail and results oriented are required.
- Ability to work in a matrix and multicultural environment required.
- Proficient in written and spoken English is required.
Travel on the Job:
Yes, international
Percentage Travel
approx. 25%
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