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:

• Responsible in qualification, evaluation and monitoring activities of new suppliers and partners for Illumina products and outsourced services
• Collaborates with cross-functional subject matter experts to coach and represent partner and service supplier processes.
• Participate as a core/extended Quality team member of new product development and sustaining teams to assure processes are in place to design and release highly reliable and safe products
• Drives process, quality and product improvements through supplier and partner development activities, risk management, identification and resolution of current and potential issues
• Responsible for updates to purchasing control procedures and processes as needed to stay compliant to quality system requirements and regulations. Provides Quality Assurance expertise and guidance for Service Supplier, Partner Development, and Product Quality
• Leads and facilitates Quality Investigations and CAPA / SCARs to resolve Quality issues with Service Supplier and Partner, ensuring mitigations, containment and corrective actions are implemented in a timely manner
• Leads supplier / partner audits to drive process standardization and continuous improvement, including audit action timely resolution and closure.
• Support Global team initiatives including supplier / partner performance reviews, corporate and site Quality Management Reviews and more.
• Supports regional initiatives associated with Service Supplier and Channel Partner process improvements and issue resolution.
• Make recommendations, and drive programs to improve channel partners and service supplier performance
• Reviews non-conformance, Quality Investigations, Complaints and CAPA reports to identify actions needed to track and improve program health by site or globally.
• Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications
• Ability to provide training to other team members to ensure consistency and compliance to processes and procedures.

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:

• Experience collaborating with cross-functional product development and operational teams (Global HQ teams and local / regional teams)
• Strong QMS auditing (ISO 13485, ISO 9001, ISO 17025) experience
• Strong communication, presentation and negotiation skills
• Working knowledge and experience with Quality Management Systems, Project Management, and Process Engineering methodologies and tools
• Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR) and Risk Management (FMEA) activities.
• Demonstrated capability in successfully managing and leading change
• Practice identifying, mitigating, and resolving risks
• Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities
• Demonstrated experience in Supplier Quality and Management activities such as component qualification, audits, risk assessments.
• Experience with electronic product life cycle (PLM) systems such as EtQ, SAP or other PLM systems.
• Practical experience in FDA and ISO regulated environments is a plus
• Experience with statistical analysis
• Ability to travel domestically and internationally as needed. Estimate 25% of the time.
• Ability to work PST hours to collaborate with teams in HQ in San Diego

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:

• BS or equivalent in a technical discipline with 5+ years of experience.
• MS in a technical discipline with 3+ years of experience.
• PHD in a technical discipline with 1-3 years of experience.
• Experience working in a regulated environment, in-vitro diagnostics preferred.

Scope of Responsibilities:

• Applies core knowledge and understanding of area of specialization to provide solutions in creative and effective ways.
• Assesses unusual circumstances and uses sophisticated analytical and problem-solving techniques to identify cause and suggest variations in approach.
• Works on assignments of diverse scope where information is limited and problem solving requires adaptation of existing techniques.
• Enhances internal and external working relationships and networks with senior partners within area of expertise.
• Adapts style to differing audiences and often advises others on difficult matters that require persuasion.
• Work is done independently and is reviewed at critical points.
• Uses evaluation, judgment, and interpretation to select best course of action.

Experience / Education:

• Typically requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree; or a PhD without experience; or equivalent work experience.

Leading-Biotechnology-Company