Abbott Senior Quality Assurance Specialist in Santa Clara, California

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Position Summary:

This Senior Regulatory Operations and Quality Specialist position will support Abbott Vascular’s quality system requirements, and conformance to regulatory requirements. This role will be focused on leading and providing support to major projects, divisional investigations, CAPAs, and audits for the Regulatory Affairs and Operations organization. This role will drive for efficiency in procedures and practices for the Product Approvals key process. The individual will execute tasks and exercise influence generally at the senior level. The individual will provide quality system support to the regulatory affairs key process and stakeholders, worldwide affiliates, and to the Abbott Vascular business unit.

The senior individual may lead junior operations team members, developing their skills/abilities, verifying work and assisting them in being more efficient in the Regulatory Operations role.

Main Responsibilities:

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

  • Lead localized and divisional investigations for Corrective and Preventive Action under the Regulatory Affairs and Operations Product Approvals key process.

  • Provide Audit support (internal, external, corporate) for the Regulatory Affairs and Operations Product Approvals key process. Anticipate requests, provide subject matter expertise, and support audit logistics.

  • Takes initiative with SOP, DOP, BUS development and management/ review for the Regulatory Affairs and Operations Product Approvals key process.

  • Assess global regulatory emerging issues and support Emerging Issues intelligence program.

  • Collaborate with local Regulatory Affairs and worldwide affiliates to understand and improve the regulatory affairs processes and requirements.

  • Responsible for the evaluation, development and implementation of Regulatory Affairs Operations projects and major initiatives for improvement and efficiency of existing practices and systems. Facilitate and participate in project team meetings to keep projects progressing.

  • Manage regulatory documentation (issuance/ management of certs/ registrations, archival of submissions and legal/ regulatory correspondence, etc.) and archival repository - VEEVA Vault regulatory information management system (RIMS).

  • Assess external communications relative to regulations.

  • Provide regulatory input for product recalls and recall communications

  • Function as a team lead when Manager is not available, prioritizing work and facilitating issue resolution or escalation.

Accountability:

  • Individual works under minimal supervision and will independently determine and develop approach to solutions.

  • Participates in conflict resolution at the senior individual contributor level.

Influence/ Leadership:

  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.

  • Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

  • Leads departmental project team.

  • Determines goals and objectives for projects.

  • Influences middle management on technical or business solutions.

  • May interact with vendors.

Planning/ Organization:

  • Plans and organizes non-routine tasks.

  • Initiates or maintains work schedule.

  • Establishes priorities of work assignments.

Decision Making Impact:

  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

  • Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.

Minimum Education:

  • Bachelor's degree in engineering, science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, or medical fields.

Minimum Experience/Training Required:

  • Minimum 4-5 years’ experience in a regulated industry (e.g. medical products, nutritionals). Quality, Regulatory and Compliance areas are preferred. Note: Higher education may compensate for years of experience. Knowledge of regulations desired.

Background / Skills / Knowledge Regulatory Knowledge of (as applicable):

  • Strong understanding of business unit function and cross group dependencies/ relationships.

  • Work with cross-functional teams; work with people from various disciplines and cultures

  • Application of root cause analysis and critical, analytical thinking skills

  • Create project plans and timelines

  • Will perform job in a quality system environment; failure to adequate perform tasks can result in noncompliance with governmental regulations.

  • Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

  • Knowledge of principles and requirements of applicable product laws

  • Knowledge of domestic and international regulatory guidelines, policies and regulations

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com