Senior Manager, QC Chemistry
Location:
Posted:
April 09, 2016
Reference:
1600662
OBJECTIVES: 
  • 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.
ACCOUNTABILITIES: 
  • 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.

Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
  • 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. 
PHYSICAL DEMANDS: 
  • In general, the position requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs.
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or training, this could include overnight trips.
  • Requires approximately 15% travel.




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Schedule
Regular  Full-time
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