Senior Manager, QMS Process Improvements & Integrations

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

 CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

This role will conduct due diligence on target acquisitions in conjunction with Corporate Development and will develop and support strategic goals for QMS integration workstream deliverables for any realized acquisitions. This role will also develop, implement, evaluate and administer global QMS continuous improvement efforts that aligns with business goals and needs.

· Conduct due diligence activities to identify risks and opportunities and develop short and long-term integration plans for prospective target acquisitions.

· Develop QMS integration goals to meet applicable requirements, timelines, scope, budget, and Initiate programs and projects within the departmental PMO to achieve integration goals.

· Manage risk resolution and escalation pathways for workstream leads within integration projects in a timely and effective manner.

· Manage the global training process, including strategy, compliance, and documentation.

· Develop end-to-end strategy (needs assessment, design, development, implementation, and effectiveness) for the global QMS training program.

· Manage and supervise employees developing, monitoring, and implementing the Global QMS training program.

· Collaborate with SMEs on current learning needs and strategies, as well as anticipate future needs based on requirements and opportunities for improvement.

· Monitor and evaluate training program’s effectiveness and report progress or issues to leadership as appropriate

· Collaborate with cross-functional teams to identify areas for improvement and develop action plans to address them.

· Analyze data and metrics to identify trends and opportunities for improvement.

· Monitor and report on the progress of continuous improvement initiatives to senior management.

· Demonstrate the behaviors of leadership, accountability, and critical thinking throughout the department.

· Formal process development and ownership as required and evaluation thereof for process improvements.

· Be attentive, available, supportive, and responsive to ensure that deliverables are met while minimizing risks.

 

Travel:

5-10% Domestic and/or International Travel

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· Bachelor’s Degree or equivalent in Physical or Life Sciences preferred

· Project Management Professional (PMP) or Program Management Professional (PgMP) certification a plus

· 10+ years of experience in medical device/pharma industry. Experience to include ISO 13485 current version, 21 CFR 820, MDD 93/42/EEC, EU MDR 2017/745, and MDSAP are minimally required. Experience with quality systems in a global shared service model preferred.

· 5+ years of experience managing and developing staff (local or remote)

· 5+ years of leading programs and projects using recognized project management methodologies

· Advanced level experience using MasterControl, Compliance Wire, and/or other LMS and eQMS software

· Advanced level experience using advanced Microsoft Office and Project Management Tools (Word, PowerPoint, Excel, Access, Teams, Smartsheets, Trello, Jira, etc.)

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencie