Qureos Mentor

Insulet Corporation

<div><p>Job Summary
</p>Reporting directly to the Senior Director of Quality Operations, the Quality Operations Manager provides oversight of a variety of analytical functions that occur in the QC department supporting validation, testing, and reporting of in-process, pre and post sterile release, and Environmental monitoring samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities.&amp;#xa;&amp;#xa;
<p><b>Job Title: </b>Quality Operations Manager
</p><p><b>Department: </b>Quality
</p><p><b>FLSA Status: </b>Exempt
</p><p></p><p><b>Position Overview:
</b><br>
Reporting directly to the Senior Director of Quality Operations, the Quality Operations Manager provides oversight of a variety of analytical functions that occur in the QC department supporting validation, testing, and reporting of in-process, pre and post sterile release, and Environmental monitoring samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities.
</p><p></p><p><b>Responsibilities:
</b></p><ul><li>Manages various QC/QA program(s)/processes within the department (training, sample management, data review and reporting) and serves as subject matter expert (SME).
</li><li>Coordinates and facilities QC/QA activities to meet commitments on-time
</li><li>Ensure QC/QA personnel have appropriate training and competency
</li><li>Leads planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification, as required
</li><li>Assist in troubleshooting of test methods and/or equipment as required
</li><li>Authors, review, and/or approves data, SOPs, COAs, DHRs and other documents as needed
</li><li>Monitor, track publish and report QC/QA metrics (NCMR, CAPA, etc.) at the Operations meetings. As necessary analyze QC/QA metrics to identify trends and actions necessary to correct adverse trends
</li><li>Ensure all QC/QA records and DHR documentation adhere to cGMP/GDP expectations
</li><li>Leads compliance related teams working towards the goal of continuous improvement
</li><li>May be required to lead NCMR, OOT investigations/deviations and to identify corrective actions to prevent reoccurrence
</li><li>Integral part of Plant Leadership team and serves as QC/QA representative in cross-functional, cross-departmental working teams
</li><li>Participates in internal and external quality audits
</li><li>Manage Supervisors and Technicians to ensure
</li><li>Recruits, coaches, and develops organizational talent
</li><li>Perform other duties as assigned
</li></ul><p></p><p><b>Education and Experience:
</b></p><p><b>Minimum Requirements:
</b></p><ul><li>BS degree in scientific discipline; and/or equivalent combination of education and experience
</li><li>Minimum of 8 years&rsquo; experience of relevant experience in Quality Control / Quality Assurance
</li><li>Minimum 2 years&rsquo; managerial experience
</li><li>Minimum 2 years&rsquo; experience in Operations Quality Management
</li><li>Must possess strong leadership and analytical skills with team-focused attitude
</li></ul><ul><li>Experience leading or supporting FDA and ISO 13485 inspections preferred
</li><li>Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
</li></ul><p></p><p><b>Preferred Skills/Competencies:
</b></p><ul><li>Excellent interpersonal, verbal, and written communication skills
</li><li>Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
</li><li>Ability to communicate and work effectively at multiple levels within the organization
</li></ul><ul><li>Advanced PC skill, word processing, spreadsheet, and database
</li></ul><p></p><p><b>NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite
</b></p><p></p><p>Additional Information:
</p>&amp;#xa;&amp;#xa;Compensation &amp; Benefits:&amp;#xa;&amp;#xa;For U.S.-based positions only, the annual base salary range for this role is $110,900.00 - $166,325.00&amp;#xa;&amp;#xa;This position may also be eligible for incentive compensation.&amp;#xa;&amp;#xa;We offer a comprehensive benefits package, including:&amp;#xa;&bull; Medical, dental, and vision insurance&amp;#xa;&bull; 401(k) with company match&amp;#xa;&bull; Paid time off (PTO)&amp;#xa;&bull; And additional employee wellness programs&amp;#xa;&amp;#xa;Application Details:&amp;#xa;This job posting will remain open until the position is filled.&amp;#xa;To apply, please visit the Insulet Careers site and submit your application online.&amp;#xa;&amp;#xa;Actual pay depends on skills, experience, and education.
<p></p><div><p>Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet&rsquo;s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
<br>
<br>
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
</p><p></p><p>At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
</p><p></p><div><div><div><div><div><div><div><p>( Know Your Rights )</p></div></div></div></div></div></div></div></div></div>

Manager, Quality Operations (Onsite - Acton, MA)

<div><p>Job Summary
</p>The Sr. Director, Enterprise Cyber Security / Deputy CISO is a key leadership role shaping the future of Insulet&rsquo;s global security program.
<br>
<br>
Reporting to the CISO, you&rsquo;ll guide enterprise‑wide security strategy&mdash;from team leadership and budgeting to protocols and incident response&mdash;while advancing a modern, comprehensive information security and privacy framework.
<br>
<br>
This is an exciting opportunity to ensure our cyber, product, patient, and corporate asset security programs are tightly aligned with Insulet&rsquo;s business goals and growing global footprint.&amp;#xa;&amp;#xa;
<p>Position Overview:
<br>
The Sr. Director, Enterprise Cyber Security / Deputy CISO oversees enterprise security measures throughout the organization. This senior-level position will participate in strategic oversight of every aspect of security - from staffing and budgets to protocols and incident response. Reporting to the CISO you will continue to develop and deliver a comprehensive information security and privacy program for Insulet Corporation global operations. Additionally, you will be responsible for ensuring the information/cyber security program is aligned with both IT and Corporate risk and business objectives with a focus on product, patient and corporate asset security.
</p><p></p><p>Responsibilities:
</p><ul><li><p>Lead and mature global cybersecurity operations across corporate, product, manufacturing, patient, and clinical environments.
</p></li><li><p>Serve as Deputy CISO, supporting the CISO in executive, regulatory, audit, customer, and operational engagements.
</p></li><li><p>Partner with the CISO, CIO, and business leaders to align cybersecurity strategy, investments, and priorities to enterprise risk and business objectives.
</p></li><li><p>Oversee security monitoring, threat detection, incident response, vulnerability management, threat intelligence, and remediation activities.
</p></li><li><p>Lead cyber investigations, crisis response, and incident recovery efforts with clear executive communication and recommended actions.
</p></li><li><p>Manage relationships with managed security service providers and ensure continuous monitoring of enterprise assets, threats, vulnerabilities, and events.
</p></li><li><p>Partner with Product Security, R&amp;D, Quality, and Regulatory teams to support secure medical device development, threat modeling, risk analysis, testing, and post-market cybersecurity activities.
</p></li><li><p>Support cybersecurity alignment with applicable frameworks and regulatory expectations, including FDA guidance, NIST CSF, ISO 27001, CIS Controls, and healthcare security standards.
</p></li><li><p>Lead cybersecurity governance, policies, standards, procedures, and controls that support business growth and operational resilience.
</p></li><li><p>Drive modernization of security capabilities across cloud, identity, endpoint, network, infrastructure, OT, and manufacturing environments.
</p></li><li><p>Partner with IT, Legal, Privacy, Compliance, Internal Audit, and business stakeholders to manage cyber risk and remediation.
</p></li><li><p>Oversee third-party cybersecurity risk related to suppliers, managed service providers, and strategic partners.
</p></li><li><p>Establish cybersecurity KPIs, KRIs, dashboards, and reporting for executive leadership.
</p></li><li><p>Manage cybersecurity budgets, forecasts, vendor relationships, and strategic investment planning.
</p></li><li><p>Lead, mentor, and develop cybersecurity team members while promoting accountability, collaboration, and continuous improvement.
</p></li><li><p>Identify opportunities to reduce risk, improve efficiency, optimize costs, and increase business value.
</p></li></ul><p></p><p>Education and Experience:
</p><ul><li><p>Bachelor&rsquo;s degree in Information Security, Computer Science, Engineering, or related field required; advanced degree preferred.
</p></li><li><p>12+ years of progressive cybersecurity, information security, or enterprise technology experience.
</p></li><li><p>7+ years of leadership experience managing cybersecurity programs, teams, and strategic initiatives.
</p></li><li><p>Experience in regulated industries such as healthcare, medical devices, life sciences, or manufacturing preferred.
</p></li><li><p>Strong knowledge of cybersecurity operations, incident response, vulnerability management, cloud security, identity security, security engineering, and enterprise risk management.
</p></li><li><p>Experience with frameworks such as NIST CSF, ISO 27001, CIS Controls, and/or HITRUST.
</p></li><li><p>Strong understanding of healthcare and medical device cybersecurity expectations, including FDA cybersecurity guidance.
</p></li><li><p>Experience presenting cybersecurity strategy, risk, and program maturity to executive leadership.
</p></li><li><p>CISSP required; CISM, CRISC, CCSP, GIAC, or similar certifications preferred.
</p></li></ul><p></p><div>Physical Requirements (if applicable):
<br>
<ul><li>Must be able to lift and transfer monitors and desktop systems (~20 pounds).
</li></ul></div><p></p><p>NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office). #LI-Hybrid
</p><p></p><p>Additional Information:
</p>&amp;#xa;&amp;#xa;Compensation &amp; Benefits:&amp;#xa;&amp;#xa;For U.S.-based positions only, the annual base salary range for this role is $204,400.00 - $306,550.00&amp;#xa;&amp;#xa;This position may also be eligible for incentive compensation.&amp;#xa;&amp;#xa;We offer a comprehensive benefits package, including:&amp;#xa;&bull; Medical, dental, and vision insurance&amp;#xa;&bull; 401(k) with company match&amp;#xa;&bull; Paid time off (PTO)&amp;#xa;&bull; And additional employee wellness programs&amp;#xa;&amp;#xa;Application Details:&amp;#xa;This job posting will remain open until the position is filled.&amp;#xa;To apply, please visit the Insulet Careers site and submit your application online.&amp;#xa;&amp;#xa;Actual pay depends on skills, experience, and education.
<p></p><div><p>Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet&rsquo;s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
<br>
<br>
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
</p><p></p><p>At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
</p><p></p><div><div><div><div><div><div><div><p>( Know Your Rights )</p></div></div></div></div></div></div></div></div></div>

Sr Director, Cyber Security Operations / Deputy CISO (Hybrid - Acton, MA)

Join Insulet Corporation and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Insulet Corporation

About Company

Manager, Quality Operations (Onsite - Acton, MA)

Sr Director, Cyber Security Operations / Deputy CISO (Hybrid - Acton, MA)