Senior Manager, Investigations

Location: Northern

## Senior Manager, Investigations Apply locations:
USA - OH - West Chester time type:
Full time posted on:
Posted Yesterday job requisition :
R-107044A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit (Use the "Apply for this Job" box below). Senior Manager, Investigations leads the site team that conducts investigations in support of Deviations and Complaints, ensuring investigations and root cause analyses are completed in an effective, compliant, and timely manner. As the subject-matter expert (SME) in problem-solving and root cause analysis, they set team standards and priorities, coach the team on appropriate tools, and guide the identification of true root causes and risk-appropriate corrective and preventive actions.

As Business Process Owner (BPO) for Investigations, they maintain procedures and metrics, represent the site in cross-site forums, and partner with Quality to ensure rigor and sound risk management.#
** Job Responsibilities
**** Core Responsibilities
*** Prioritize and level-load the Investigation Team’s work to enable timely decisions and on-time completion of investigations; escalate issues as appropriate.
* Guide the site on deviation standards and drive improvements to investigation processes.
* Lead cross-functional investigations to root cause, selecting and applying approved problem-solving tools to keep the team on schedule.
* Direct organized investigations with a defined scope, strategy, and timeline, documenting the status and progress of the investigation and associated CAPAs.
* Align cross-functional partners on communication and investigation strategy, a clear and actionable problem statement, root cause, solution selection, and the CAPA action plan and effectiveness checks.
* Work within and across sites to connect investigations across functional areas.
* Promote continuous improvement in quality, efficiency, production, and safety through team-driven processes, key performance indicators, and recognition of high performance.
* Seek and leverage internal and external expertise to improve the speed and rigor of investigations.
** Documentation & Compliance
*** Serve as Business Process Owner (BPO) for Investigations, maintaining investigation procedures, standards, and metrics and representing the site in relevant cross-site forums.
* Maintain deviation metrics and report on investigation performance.
* Author investigation reports that document the problem definition, scope, product impact, root cause, and corrective actions to prevent recurrence.
* Partner with Quality to ensure efficiency, rigor, and sound risk management across investigation processes.
** Training & Development
*** Coach, train, and develop direct reports to optimize performance and ensure each person understands the contribution they make.
* Lead the Investigation Team with a focus on people management and coaching to build and sustain a high-performing, diverse organization.
* Serve as the site’s subject-matter expert (SME) and trainer in problem-solving and root cause analysis, educating contributors on investigation processes.# Experience & Education
** Minimum*
* ** Qualifications
* ** Experience in pharmaceutical manufacturing or another similar regulated industry, including leadership or people-management experience.
* Ability to assess and assimilate technical data, conduct thorough investigations, and identify the critical factors needed to generate effective, risk-appropriate solutions.
* Excellent technical writing and verbal communication skills, with the ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
* Thorough understanding of core business processes, including relevant cGMP and regulatory requirements.
* Ability to prioritize and manage multiple activities in a fast-paced, rapidly changing environment to meet…