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Head of Quality Assurance

4 months ago

San Diego, United States Revvity Full time

BioLegend (a division of Revvity, Inc.) strives for continuous improvement and future growth, we seek an experienced, passionate, and dynamic Director to oversee all Quality Assurance functions. We are looking for someone who is organized, committed, and passionate about the job, and someone who possesses clear communication skills in all aspects. In this role, you will have a hands-on role in defining, deploying, and leading organizational, process, and product quality requirements throughout the total product life cycle to fulfill the applicable global requirements. Your main functions will be to improve patient outcomes, meaningfully impact the company’s short-term and long-term success work closely with executives across the organization, play an active role in how this position contributes to the overall company strategy, learn about new innovative technologies, and utilize our collaborative company culture to create an inspiring and productive workplace.

**Essential Functions**

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Responsible for Continuous Improvements of the BioLegend Quality Management System including: Management Review, Change and Document Control, Records Management, Validations, Audit and Inspection Management, Corrective and Preventive Action Management, Complaints, Failure Analysis, Risk Management per total product life cycle, Nonconformance Management, Distribution Quality, Supplier Quality, and Manufacturing Quality
- Serve as the Deputy Management Representative per ISO 13485 requirements.
- Work closely with Productions for batch reviews and product release as needed.
- Support the Process Owners, Operations Engineering team, and Facility for the required Validations and Verifications with required records.
- Provide Quality Management System training to all employees and capture the required training records with traceability.
- Work collaboratively with Regulatory Affairs and Research and Development regarding Product Development (Design) Controls, Design Assurance, and Labeling Control
- Ensure effective implementation of Quality Management Systems and Compliance requirements across BioLegend
- Ensure that a highly effective and motivated Quality Assurance team is in place to meet the needs of the business, including budgeting, staffing, training, performance management, and personnel development
- Guide manufacturing and design groups with Quality Systems and Compliance interpretation, establishment, and maintenance
- Develop a strong working relationship with internal partners to ensure compliance with regulatory requirements, and provide appropriate quality support across all business units
- Prepare, present, defend, and manage the Quality and Compliance departmental budget and staff.
- Interface with government authorities regarding Quality System and Compliance issues
- Monitor the activities of government regulatory authorities on a worldwide basis to ensure that the business is able to align with, comply with, and anticipate changes
- Lead team for the due diligence and integration activities as needed
- Other duties as assigned

**iACT Competencies**
- **innovate **- Be better, keep improving, be more efficient, creative, and be in the forefront of development
- ** Aspire **- Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
- ** Collaborate **- Foster teamwork, common goals, selflessness, communication and mutual support
- ** Transform **- Adapt, learn, re-invent and change for future development and growth

**Minimum Qualifications - Education and Experience**
- Bachelor of Science degree in biological or scientific discipline
- A minimum of 12 years of related experience in the medical device and/or diagnostics industry
- 6 years of people management experience
- High energy, results-oriented leader with excellent collaboration and eQMS experience
- Ability to utilize sound judgment and decision-making capabilities in technical, business, and regulatory compliance arenas
- Strong expertise in domestic and international regulatory compliance requirements (e.g. FDA QSR, ISO/EN standards, and MDSAP)
- Possess a deep Quality Engineering toolbox including Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Design for Six Sigma, Industrial Statistical Methods, Six Sigma and/or Lean Manufacturing
- Experience leading internal audit programs and managing external inspections/audits (e.g. FDA, Competent Authorities, Notified Bodies)
- Experience dealing with government regulatory bodies, Competent Authorities, and Notified Bodies
- Ability to effectively interface with stakeholders internally and externally

**Preferred Qualifications - Education and Experience**
- Certified Quality Auditor or equivalent
- Experience moving from a paper-based eQMS system to an electronic-based system
- Famil