Manager Quality Systems and Regulatory Compliance

Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In our facilities in Solna / Sundbyberg we develop and manufacture diagnostics tests that improve patient outcome all over the world




POSITION SUMMARY:


The Manager will Manage Quality Systems (QS) processes and related deliverables in conjunction with Company objectives and Regulatory requirements. Mentors and provides ongoing teaching, guidance and assistance of process owners, CAPA stakeholders, internal auditors, managers and their team to ensure awareness of regulatory requirements.
Interact with global QS counterparts in the headquarter to ensure a good alignment of QS processes


ESSENTIAL JOB RESPONSIBILITIES:


Lead and monitor Solna site audits and Quality system inspections readiness
Lead and develop Cepheid Quality System team ensuring Cepheid AB has continuous compliance with the corporate Quality Policies and applicable regulatory requirements
Lead the Quality System team to ensure compliant and timely deliverables, such as internal audit program, Quality training program for Solna site, CAPAs, Corrections, etc…
Participate to the definition of annual quality goals and quality plans
Lead the Quality System Management reviews
Monitor Quality key performance indicators and coordinate Problem Solving Plan cross-functional teams where needed
Manage CAPA process and ensure compliant and timely deliverables of corrective and preventive actions.
Provide guidance and trainings in multiple Quality and Regulatory related disciplines to cross-functional groups
Promote and develop standardization and simplification of QS documentation, and facilitate continuous QS process improvement
Develop tools for the efficient monitoring of QS deliverables (use of visual and daily management)
Control and approve QS document changes



MINIMUM REQUIREMENTS:
Education or Experience (in years):
At least five years experience in Quality Assurance, in the diagnostics / medical device industry
Excellent skills in written and verbally (English required)



Knowledge and skills:


Qualified Quality System auditor (ISO9001 – ISO13485)
Knowledge of risk management standard (ISO14971) and tools (FMEA, FTA etc..)
ISO 13485, 21CFR Part820, MDSAP related regulations
Experience or capacity to lead and develop associates



Other:


High adaptability and flexibility
Multi-tasking ability
Strong leadership and excellent communication skills
Ability to prioritize, sense of urgency
Can provide clear objectives and support associates for their achievement
Careful and thorough



PREFERRED REQUIREMENTS (optional):


Experience of international multi-site company