- Supervise and mentor QC Supervisors/ Managers as well as support staff.
- Responsible for leading and managing complex projects of diverse scope within QC and cross-functionally.
- Proactively plans and prioritizes lab operations and resolves quality and compliance issues.
- Independently exercises judgment for broadly defined practices, procedures and policies to select methods, techniques and evaluation criterion.
- Decisions have a high impact on future Quality Control processes and procedures and may affect other departments within the organization.
- Uses judgment and experience to troubleshoot problems and formulate solutions.
- Represents QC business processes across the organization, particularly as it applies to method transfers and expanding laboratory operations.
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Demonstrate an in-depth theoretical understanding of laboratory operations, systems, methods and regulatory compliance across analytical and bioanalytical chemistry disciplines.
- Demonstrate an understanding of company priorities, objectives and project timelines.
- Effectively communicate priorities to staff and deliver on-time results.
- Apply scientific judgment to review work and contribute to milestones related to specific projects.
- Interact with management to review FTE requirements, annual budgeting and other business needs.
- Responsible for maintaining a compliant training program for all staff.
- Proactively encourage identification of system improvements in laboratory operations.
- Work with analysts and employees from other departments to troubleshoot problems of broad scope that encompass multi-faceted project/experimental areas.
- Provide guidance to analysts supporting contract laboratory testing to ensure timely results in accordance with site priorities.
- Review SOPs, studies, validation documentation, change controls and investigations to maintain compliance.
- Demonstrate an understanding of how method performance impacts the business.
- Apply knowledge of cGMPs on a daily basis.
- Manage day-to-day operations independently.
- Delegate responsibility and projects to QC management and lead analysts based on their level of judgment and experience.
- Meet with individual employees on a regular basis to discuss, prioritize, and assign laboratory work and projects.
- Meet with functional group on a regular basis to discuss routine laboratory functions, individual projects and departmental goals.
- Independently manage personnel development, annual performance reviews and performance issues with minimal guidance.
- Proactively looks for ways to challenge analysts and create career opportunities to enhance job satisfaction and improve the department as a whole.
- Bachelors or Master's Degree in any Life Sciences with relevant laboratory coursework and 10+ years of relevant experience, 5+ years management experience preferred.
- Previous industry experience in a regulated environment required.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Exceptional leadership skills required.
- Must be able to read, write and converse in English.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Knowledge of cGMP manufacturing preferred.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- In general, the position requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs.
- Willingness to travel to various meetings or training, this could include overnight trips.
- Requires approximately 15% travel.
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