Sr Manager, Quality Systems

Job Summary

The Senior Manager, Quality Systems is accountable for providing oversight for local quality systems compliance and procedures. The position is responsible for reporting on the health of regulatory compliance and partnering with functional managers to develop and maintain scalable, compliant systems. In addition, the Senior Manager, Quality Systems will represent the local quality system in global and divisional initiatives expected to impact the local quality system and host and facilitate effective third-party audits.
• Salary Range: $137,021 - $190,000
• Position is eligible to participate in a bonus plan with a target of 14% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.

Responsibilities

• Develops and delivers quality and compliance strategies in alignment with global and divisional requirements and local and international regulations and standards. 
• Ensures that short and long-range quality plans and goals related to areas of responsibility are aligned with global, divisional, and local objectives. 
• Responsible for development, maintenance, and improvements to the and local quality system activities: 

• Document Control
• Design Control
• Medical Device Risk Management
• Software Development Lifecycle
• Training
• Internal and External Quality System Audits
• Management Review
• Divisional KPIs
• CAPA/Nonconformance management
• Product holds
• Supplier management

• Provides quality leadership, guidance, and support for all distributed products. 
• Develops and implements a cross-functional internal audit program to ensure that all worldwide 
• regulatory and global quality system requirements are implemented and met. 
• Represents the local quality system during regulatory and external inspections. 
• Reports to management on compliance health, inspection readiness and audit results by managing local regulatory and external audits by providing the following activities:
• Pre-inspection readiness:

• Pre-audits
• Training
• Logistical preparations
• Staging room
• Inspection activities:
• Inspection facilitation/mediation
• Escorts
• Audit room management

• Post-inspection activities:
• Formulation and review of audit responses
• Verifying implementation and effectiveness of corrective actions
• Follow-up audits
• Drives QMS initiatives to ensure standardization throughout the organization. 
• Partners with and leads functional quality management to develop and maintain high performing, scalable and compliant quality systems. 
• Provides leadership and guidance for effective and timely communication and appropriate escalation of quality system issues to all levels of the organization. 
• Benchmarks across sites to identify and support strategic new systems, leverage resources, and expertise to develop and implement Best Demonstrated Practices
• Develops proactive and collaborative working relationships across key disciplines, including but not limited to; R&D, Clinical/Medical Affairs, Operations and Post Market Quality. 
• Supports due diligence and business integration activities as required. performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to OHSAS 18001 and ISO 14001

Requirements

• Master’s degree in a life science, engineering, physical science, or related discipline preferred, bachelor’s degree with commensurate experience may be considered.
• At least ten to fifteen years of experience in medical devices or similarly regulated industry is required.
• At least five years of experience serving as a quality system SME, including accountability for quality systems governance and inspection support is required.
• At least five years management experience in a medical device quality systems function.
• Must have strong specific knowledge of quality system requirements with knowledge of the QSR, ISO, MDD, MDSAP and MDR requirements.
• Lead Auditor or ASQ professional certification required (i.e. ISO 9001/13485 lead auditor, ASQ CQA, etc.)
• Ability to communicate ideas and concepts, both verbally and in writing, to all levels of the organization.
• Ability to prioritize multiple high-risk projects to ensure compliance with regulations and standard operating procedures.
• Excellent formal and informal communications skills as well as problem solving, collaboration and influencing skills.
• Must have the ability to act as a change agent and drive/influence change as well as effectively lead and motivate team members to achieve team goals. Must be conversant in the technologies which are being used by subordinates.
• Must be capable of operating in a computing environment that consists of PC, and Windows.  
• Must be self-motivated, have good interpersonal skills and capable of analyzing and solving complex problems.
• Requires excellent formal and informal communications skills.
• Experience managing a department that provides complete product related data management to support product development, pre-production quality assurance, production, and quality systems.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.