Senior Manager, Quality Systems

Reporting to the head of Global Quality Systems the Sr Manager Quality Systems is responsible for supporting the global design standardization governance and continuous improvement of core quality system processes across all business units and geographies. This position ensures that quality processes are effective compliant and aligned with both regulatory requirements and business objectives. The Sr Manager Quality Systems partners cross functionally to drive harmonization digital enablement and operational excellence across Quests global quality landscape.

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 Capistrano 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

• Support the development of global policies procedures and standards in alignment with ISO FDA CLIA CAP and other applicable regulations.
• Support a global roadmap for process maturity automation and integration with other quality and business processes.
• Monitor performance and compliance of KPIs and process health metrics through dashboards audits and reviews.
• Partner with Regulatory Affairs to assess the impact of emerging regulations and ensure proactive compliance
• Serve as a change agent to drive adoption and behavioral alignment with global standards.
• Collaborate with the Global Process Owner (GPO) and develop training materials and deploy role-based training content for the quality system processes.
• Partner with GPO IT and QARA project management teams to define user and functional requirements and enable process automation.
• Support system configurations validation and integration projects that impact the quality processes.
• Engage with GPOs Site Quality leaders Operations R&D IT Legal and other stakeholders to ensure global process alignment and effectiveness.
• Participate in 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.

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

Education

• Bachelors Degree Bachelors degree in Life Sciences Engineering Quality or related field. (Required)
• Masters Degree (Preferred)