Global Process Owner for the Internal & Corporate Audit Programs
- Plans, coordinates, and executes internal QMS and/or product-focused audits to assess the compliance and effectiveness of the overall QMS of the organizational unit(s) being audited.
- Reviews responses to audit findings for completeness and effectiveness
- Ensures suitable responses to audit non-conformances are provided by auditees within agreed upon timeframe
- Provides support ensuring external audit readiness and during external audits
- Identifies at risk business needs for compliance support through the monitoring of actions and the assessment of compliance data, and assists organizational units in addressing compliance deficiencies
- Defines, establishes, monitors & improves training on key compliance topics
- Establishes an internal audit program at Illumina manufacturing sites and within regions
- Identifies and shares audit best practices
- Participates in Quality & Regulatory initiatives as a cross functional contributor
- Establish front-runner internal & corporate audit programs that meet global regulatory requirements
- Provide strategic guidance to drive global QMS certification scheme management, integration activities and due diligence efforts.
- Advise and consult on project, quality, risk and remediation plans.
- Global Collaboration: Direct audit inputs to the QMS clarification & simplification efforts to ensure compliance for research and diagnostic applications using a risk-based approach.
- QMS Geographical Expansions: Direct audit inputs to inter-site transition planning and execution for revised regional regulatory requirements (MDSAP, IVDR, etc.).
- Training: Develop and conduct Quality System Regulation/GMP, ISO and other targeted QMS training programs to foster a culture of quality across all levels. Coaches and mentors team members.
Accountable for the second (customer) and third-party (audit organization) relationships
- Direct staff to provide optimal tactical readiness (schedule, plan, perform) and response to customer visits and regulatory audits/inspections. Partner with the business to develop and drive risk response programs.
- Collaborative leader to proactively build & strengthen organizational partnerships (Legal, Commercial, GQO, regional QA/RA leaders, etc.) to establish a robust Customer Alliances Program with adequate monitoring & feed loops to ensure ILMN’s adherence to quality terms.
- Ensure audit findings and risks are clearly communicated; and corrections and CAPAs are appropriate to risk level.
- Advocate strategically and operationally effective solutions to complex QMS problems. Advise and consult on project/quality, risk and remediation plans.
- Global influence includes traveling to other sites.
- Handles difficult personnel situations directly, using appropriate discretion, HR advice, and respect for the individual.
- Exhibits strong business partnering competencies – particularly in the areas of ‘business acumen’ and ‘consulting skills
- Exhibits professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
- 10+ years of related experience in a medical device, IVD, biologics or Pharma industry 10+ years of Quality Management and Quality System Auditing/Training within the medical devices industry.
- Current certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Auditor (CQA).
- Expert understanding in meeting and applying medical device regulations and standards (e.g. 21 CFR 803/806/820, ISO 13485, ISO 14971, MDR, IVDD/IVDR) and Medical Device Single Audit Program international regulations is a plus (US, Australia, Brazil, Canada, Japan), and ISO 9001.;
- Demonstrated ability to understand and develop Quality processes, with flexibility of application to medical/IVD or non-IVD (e.g., RUO, laboratory) environments.
- Experience in leading global cross-functional teams.
- Proven ability to influence management and network at all levels.
- Demonstrated ability to initiate process improvement and take initiative; transformation expertise preferred.
- Direct experience and successful interface management with external parties with regulatory bodies (US inspections/EU audits required, additional regions is preferred); experience in managing ISO certifications is required.
- Functional experience in quality, regulatory, manufacturing and/or development roles in a regulated (FDA, ISO) manufacturing environment.
- 5+ years’of management experience.
- 5+ years’ experience in audit/inspection preparation/remediation activities, or equivalent training.
- Expert understanding of CFR, ISO and ICH guidelines governing clinical research, and of applying principles of 21 CFR Part 11 to clinical systems.
- Detail-oriented and able to work independently
- Bachelor’s degree in a scientific or engineering discipline (or equivalent experience) required
- Advanced degree in a scientific, quality and/or business discipline strongly preferred
- Talent Acquisition activities: identifies needs of the department and justifies budget to fill those positions; coordinates with HR to market the position, review resumes and conducts interviews, and identifies and recommends candidates as potential hires; conducts employee orientation to the department and company.
- Talent Development activities: develops training plans with employees to ensure they have the necessary expertise to successfully perform their jobs; provides ongoing guidance to employees and provides career counseling to help employees develop and advance in their careers
- Job Role Definition: ensures that job descriptions accurately record the primary responsibilities, qualifications and terms for each job role in their group
- Performance Management: sets performance standards; ensures employees have appropriate and realistic job goals; provides ongoing performance feedback and conducts performance appraisals, which includes developing employee improvement plans if necessary as well as accomplishment reward/recognition
- At higher levels of management, establishing and distributing budgets among departments is required.
- Ensure employees follow all applicable company policies and procedures