Job Description

About Leading-Biotechnology-CompanyANSR, a market leader in enabling organizations to build, manage and scale global teams, is partnering with a renowned biotechnology company who is redefining the future of human health by providing solutions to some of the most complex problems in the healthcare industry. They are committed to making precision medicine accessible and carries out their business operations in an environmentally sustainable way.Now is your opportunity to join their innovative team in Bengaluru, India. For over 20 years now, companies cutting across size, industry and markets have relied on ANSRxe2x80x99s expertise to successfully build global business and technology teams. We can help you land a rewarding career in this dynamic industry.If you are eager to contribute to a company with strong values, a supportive environment and where you get opportunities to work on challenging projects that uses cutting-edge technology to improve millions of lives, this is your chance to join a truly remarkable team. Apply today!ANSR is hiring for one of our client.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:

• Bachelors 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.

Leading-Biotechnology-Company