Senior Manager, Quality Systems (Global Process Owner)

Reporting to the head of Global Quality Systems the Sr Manager- Global Process Owner (GPO) is responsible for the global design standardization governance and continuous improvement of a core quality system process across all business units and position ensures that the assigned quality process is effective compliant and aligned with both regulatory requirements and business GPO partners cross functionally to drive harmonization digital enablement and operational excellence across Quests global quality landscape.

This position will serve as a Global Process Owner for Change Control.

Preference will be given to someone residing close to one of our Major labs in (Pittsburgh PA; Houston TX Lenexa KS; Marlborough MA; Dallas TX; Wooddale IL Tampa FL; Chantilly VA; Clifton NJ San Juan Capastrino CA)

Work Schedule: Hybrid ( 3 days onsite 2 days work from home)

Internal Grade: 51

Preference will be given to someone with regulated healthcare life sciences or diagnostics background.

***No sponsorship available***

Pay Range: $110000 - $160000/ year

Salary offers are based on a wide range of factors including relevant skills training experience education and where applicable certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy happy lives. Our pay and benefit plans have been designed to promote employee health in all respects physical financial and developmental. Depending on whether it is a part-time or full-time position some of the benefits offered may include:

Medical/Prescription Drugs

Dental

Vision

Flexible Spending Accounts (FSAs)

Supplemental Health Plans

401(k) Plan Company match dollar-for-dollar up to 5%

Employee Stock Purchase Plan (ESPP)

Supplemental Life Insurance

Dependent Life Insurance

Short- and Long-Term Disability buy-up

Blueprint for Wellness

Emotional Well-Being Resources

Educational Assistance

Paid time off / Health Time

Variable Compensation Plans

Sales Incentive Plans

• Own end to end global process design and performance for the assigned quality system element.
• Develop global policies procedures and standards in alignment with ISO FDA CLIA CAP and other applicable regulations.
• Establish and drive a global roadmap for process maturity automation and integration with other quality and business processes.
• Define KPIs and process health metrics; monitor performance and compliance through dashboards audits and reviews.
• Serve as the primary decision maker for global process-related escalations deviations and change initiatives.
• Partner with Regulatory Affairs to assess the impact of emerging regulations and ensure proactive compliance.
• Lead change management efforts to drive adoption and behavioral alignment with global standards.
• Collaborate and develop training materials and deploy role-based training content for the process.
• Partner with IT and e-Quality Management Systems project management teams to define user and functional requirements and enable process automation.
• Support system configurations validation and integration projects that impact the quality process.
• Serve as the approver on CSV validation documents ensuring Part 11 compliance
• Engage with Site Quality leaders Operations R&D IT Legal and other stakeholders to ensure global process alignment and effectiveness.
• Facilitate global communities of practice and user forums for continuous feedback and best practice sharing.
• Participate in corporate and/or health authority inspections/audits when local SMEs have not been able to satisfy auditor requests or questions.
• Serve as owner and business system administrator of technology tool

Required WorkExperience:

• 8 years of experience in Quality Assurance Quality Systems or Regulatory Compliance with at least 3 years in a regulated healthcare life sciences or diagnostics environment.
• 3 year of experience of global or local process ownership or project leadership experience.

Preferred Work Experience:

• Experience in Quality and Regulatory Affairs within the diagnostics medical devices or laboratory services industry.
• Working knowledge of enterprise systems such as MasterControl Veeva Medialab Smartsolve etc.
• Demonstrated ability to lead change in a regulated environment
• ASQ ISO certification

Knowledge:

• In depth knowledge of GxP FDA CLIA and other relevant regulatory frameworks.

Skills:

• Microsoft Office 365
• Proficient in Technical / Procedural Writing

Required:

• Bachelors degree in Life Sciences Engineering Quality or related field.
• Travel up to 25%

Preferred:

• Masters Degree preferred
• ASQ ISO certification