Manager, Investigations

A 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 www.resilience.com

Position Summary & Responsibilities

The Manager, Investigations is responsible for leading a team of Lead Investigators, supporting the team through coaching on appropriate tools, and driving behaviors that support the identification of true root causes. This individual will establish practices and standards that enable Lead Investigators to ensure investigation outcomes and root cause analyses are completed in a timely, effective, and compliant manner. The speed and rigor demonstrated by this role will drive a culture that prevents repeat deviations through a robust and proactive investigation process.

The Manager, Investigations is a subject matter expert (SME) in practical problem solving and root cause analysis, including Lean tools such as Level 0 and Practical Problem Solving (PPS).

As Business Process Owner (BPO) of the investigation process, the Manager, Investigations is responsible for maintaining procedures and training materials, keeping performance metrics, and representing the site in relevant forums.

• Seeks and leverages the skills and technical expertise of internal and external resources to improve the speed and rigor of investigations
• Manages team performance by establishing standard ways of working, implementing and maintaining lean tools for tracking and visibility, and level-loading work
• Sets appropriate priorities and guides the group on continuous improvement
• Maintains standards that aid in timely decisions and completion of investigations.
• Escalates issues as appropriate.
• Coaches, trains, anddevelops direct reports to optimize performance outcomes ensure individuals understand the contribution they make.
• Promotes continuous improvement in efficiency, quality, production, and safety using team driven processes and key performance indicators and recognition and rewarding high performance.
• Act as Business Process Owner for Investigations.
• Site problem solving expert and trainer.
• Maintain deviation metrics
• Collaborates with a cross functional team to determine:
  • Communication strategy so all stakeholders have appropriate information.
  • Investigation strategy including a clear and actionable problem statement.
  • Investigation tools.
  • Investigation action plan and timing.
  • Root cause.
  • Solution selection.
  • CAPA action plan and effectiveness checks.
• Identifies and utilizes appropriate investigation tools to support teams in identification of true root cause.
• Conducts organized investigations with a well-defined scope, strategy, and timeline documenting status and progress of the investigation and CAPAs.
• Authors reports that document the investigation of issues including definition, scope, product impact, root cause, and corrective actions to prevent the recurrence of the issue.
• Works within and across functions, and sites to ensure connectivity of investigations

Minimum Qualifications

• Significant experience in Pharmaceutical Manufacturing or other similar regulated industry.
• Ability to take accountability for team performance with excellent follow through.
• Ability to prioritize activities to meet customer needs and deadlines.
• Ability to direct and participate in cross-functional teams.
• Ability to monitor activities to accomplish stated objectives in an effective manner
• Ability to work in a fast-paced and rapidly changing environment.
• Ability to present findings, conclusions, and complex information in a clear, concise, and logical manner.
• Experience with problem-solving tools.
• Excellent technical writing, verbal, and presentation skills.

Preferred Qualifications

• Bachelor’s degree in Science, Engineering, Regulatory, or other related discipline.
• Leadership experience in management or supervisory positions.
• Understanding of core business process including relevant cGMP and regulatory.
• Multiple site or function experience.
• Experience working in a lean manufacturing environment.
• Project management skills
• Proficiency with Microsoft Office Suite
• Working knowledge, or the ability to learn, computer systems such as Veeva, SAP, LIMS, and Electronic Batch Record Systems

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Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $105,000.00 - $135,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.