What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
All About Us
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.
Position Summary:
This position will act as the Quality Leader for Illumina India and partner cross-functionally to lead the Illumina India Quality Team, plus manage quality activities for the site and ensure quality compliance to applicable regulations and standards, as well as to the Illumina Quality Management System.
This position is responsible for implementation of Illumina India Quality activities, QMS and projects to improve, monitor and measure Illumina’s quality performance and compliance as well as Illumina product quality requirements for operational objectives.
All About You
Responsibilities:
- Leads organizational management of a team of dedicated Quality Specialists and Quality Engineers for Quality activities at Illumina India.
- Ensure the quality activities meet customer, corporate, and / or internal requirements and any other related requirement within the Quality Management System.
- Support the Illumina India activities with focus on compliance with Illumina QMS and applicable requirements.
- Monitor and analyze key metrics and drive improvements to QMS processes.
- Develop, review and approve quality system documents to ensure compliance with applicable regulations.
- Builds effective, cross-functional teams that accomplish sustaining, supporting and project objectives on a prescribed schedule and where applicable within a prescribed budget.
- Makes recommendations on resource needs and facilitates procurement of resources, resolution of resource conflicts, and business justifications and/or trade-offs related to resource utilization.
- Grows talent within the organization by leading employee development initiatives.
- Participates in the definition of area goals and drives teams to deliver on goals
- Drives continuous improvement initiatives to advance quality processes and capabilities.
- Advocates operationally effective solutions to complex problems.
- Contributes quality and compliance expertise and guidance to teams responsible for addressing specific quality issues.
- Establishes and monitors process metrics and develop action plans as needed
- Works with business process owners to identify and implement solutions to track and action quality KPIs.
- Act as document approver for Illumina India site when appropriate.
- Manage and/or perform internal and external compliance audits/ inspections as well as participate in management of corrective action program (i.e., audits, inspections) to ensure timely follow-up, completion and documentation of corrective actions.
- Provides management with plans and status updates on assigned responsibilities and goals and escalates issues in a timely fashion.
- Leads or provides subject matter expertise during internal and external quality system audits.
- Leads or represents functional area in Management Review and Quality Review processes.
- Provides input to core QMS processes, such as non-conformance, CAPA, and Internal Audits.
- Participates in Illumina Quality System Software assessment and remediation activities.
- Create Cybersecurity PMS Reports and PMS Risk Assessments.
- Other such duties that may be determined by Management.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties
associated with the position. Changes to individual responsibilities may occur due to
business needs.
Requirements:
- 10 years+ of relevant experience.
- Minimum 3 years of experience managing personnel.
- Quality Management System implementation and management experience.
- Must have proven experience in quality assurance within the medical device, IVD, Biotech or Pharma industry.
- Experience in regulatory affairs would be preferred.
- Experience collaborating with cross-functional leadership and operational teams.
- Experience working in a matrixed environment.
- Strong communication and negotiation skills.
- Demonstrated capability in successfully managing and leading change
- Experience with Quality, Project Management, and Process Engineering methodologies and tools.
- Experience with enterprise Training Programs preferred.
- Practice identifying, mitigating, and resolving risks.
- Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities.
- Ability to travel domestically and internationally as needed. Estimate 10% of the time.
- Based in India.
- Should be flexible to work on 2pm - 11pm shift.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Experience / Education:
- Bachelor’s degree or equivalent in Biomedical Engineering, Biological/Life Sciences.
- 10+ years of experience.
- Significant experience working in a regulated environment, in-vitro diagnostics or medical devices required.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
