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Job Function:
Quality
Job Sub Function:
Quality Documentation
Job Category:
People Leader
All Job Posting Locations:
Schaffhausen Switzerland
Job Description:
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s).
Johnson & Johnson Innovative Medicine Quality & Compliance Quality Management & Digital team is recruiting for a Senior Director Quality Systems. This is a global leadership role reporting to the Vice President Quality Management & Digital Innovative Medicine Quality & Compliance. The role is responsible for shaping operating and continuously improving the Quality Management System technology and operational landscape that enables compliant efficient and modern GxP quality processes across Innovative Medicine.
Role Summary
The Senior Director Quality Systems will provide enterprise leadership for the strategy roadmap operation and sustainment of core QMS systems and enabling platforms. This leader will partner closely with Innovative Medicine Quality & Compliance Enterprise Quality IM Digital Quality JJT Global Process Owners and regional stakeholders to ensure QMS systems support business priorities regulatory expectations inspection readiness and continuous improvement.
The role will lead global QMS system strategy business ownership system investment planning and operational services including support for Transcend QMS Operations LMS EDMS and related QMS workflows. This leader will also provide strategic direction people leadership governance and stakeholder engagement to advance a scalable compliant and digitally enabled QMS ecosystem.
Key Responsibilities
Lead the global QMS systems strategy investment roadmap and governance model to support current and future Innovative Medicine Quality & Compliance priorities.
Oversee planning execution sustainment and continuous improvement of QMS system initiatives and investments.
Serve as business owner for core QMS systems and enabling platforms including LMS EDMS QMS workflows and related operational capabilities.
Partner with Global Process Owners Enterprise Quality IM Digital Quality JJT and regional stakeholders to ensure systems are aligned with process needs quality architecture and enterprise priorities.
Provide Quality leadership and guidance for strategic system investments ensuring compliance with applicable GxP computerized system validation and quality requirements.
Develop scalable operational services and support models that enable consistent efficient and compliant QMS operations.
Represent IM Quality Systems in enterprise transformation efforts governance forums and senior leadership discussions.
Lead develop and engage a global team fostering accountability collaboration inclusion and high performance.
Monitor internal and external trends in Quality Systems and digital capability to identify opportunities for simplification standardization innovation and value creation.
Develop dashboards metrics and leadership updates to provide visibility into QMS system performance investment progress risks and opportunities.
Qualifications
Bachelors degree is required.
Minimum of 12 years of relevant experience in Quality Systems Quality Operations digital quality program management transformation leadership or a related regulated environment.
Experience with Quality Management System platforms and solutions supporting GxP processes.
Demonstrated experience shaping system roadmaps leading system investments and translating business needs into executable plans.
Strong understanding of quality systems regulatory expectations computerized system validation and continuous improvement principles.
Proven ability to influence collaborate and drive alignment across senior leaders global teams and matrixed stakeholders.
Strong strategic thinking communication presentation analytical and decision-making skills.
Experience leading teams developing talent and creating an inclusive high-performance team environment.
Ability to manage multiple priorities and deliver high-quality outcomes in a complex global organization.
Preferred Qualifications
Advanced degree such as M.S. MBA Ph.D. Pharm.D. or equivalent is preferred.
Experience in pharmaceuticals healthcare medical technology or another highly regulated industry.
Experience with QMS platforms such as Veeva TrackWise ComplianceWire EDMS LMS or similar systems.
Experience partnering with digital technology process ownership and quality organizations to deliver enterprise-scale transformation.
Experience developing metrics dashboards and executive-level updates to support decision-making and governance.
Travel
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Business Alignment Compliance Management Compliance Policies Developing Others Inclusive Leadership ISO 9001 Leadership Process Improvements Quality Control (QC) Quality Standards Quality Systems Documentation Stakeholder Engagement Standard Operating Procedure (SOP) Statistical Process Control (SPC) Systems Thinking Technical Writing
Required Experience:
Exec
Employment Type : Full-Time
Experience: years
Vacancy: 1