Abbott MGR COMPLIANCE QUAL ASSURANCE in Columbus, Ohio

At Abbott, we're committed to helping you live your 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.

JOB DESCRIPTION:

Primary Function/Primary Goals/Objectives:

Design, establish, implement and maintain an effective Quality Audit Program. Provide direction, support, leadership and management of compliance to Federal regulations, international Standards/Directives, European Norm or other applicable governing bodies and Abbott Policies as they relate to audits, manufacturing, manufacturing support, and CAPA management. Manage, lead and develop individuals who can continually support a compliant regulatory atmosphere.

Major Responsibilities:

Manage an effective Quality Audit Program. This is accomplished through :

  • Exercise independent, expert judgment to provide direction and management to all departments regarding risk and resolution.

  • Serve as a strategic player and achieve a balance of involvement and objectivity, perform risk analysis and prioritize for GMP compliance.

  • Audit compliance to federal Regulations, International standards/directives, European Norm or other applicable governing Bodies and Abbott Policies as they are relate to audits, manufacturing, manufacturing support, and CAPA management.

  • Providing technical Support as the area subject matter expert for quality System processes, procedures and Issues.

  • Keep Current with regulatory requirements, proposals and best practices via consistent surveillance of governmental publications, attending GMP/FDA seminars and meetings.

  • Disseminates regulatory requirements to appropriate personnel.

  • Providing and executing annual schedules by assessing compliance of the systems and facilities.

  • Providing feedback in the form of audit observations, formulating recommendations and determining if corrective actions and commitments have been properly implemented and are effective, and corrective actions and commitments have been properly implemented and are effective.

  • Assisting in on-site visits prior to or during an FDA or corporate audit inspection to improve compliance to regulation requirements and standards.

  • Monitoring Compliance performance and reporting appropriate metrics through CAPA and Management Review Boards and monthly reports.

Education:

  • BA or BS required with Sufficient Experience in related industry

Background:

  • Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.

  • Experience in Regulatory Affairs and/or compliance 2 years + preferred

  • 3+ years in Quality Assurance preferred

  • 2 + years in Auditing Preferred

  • The Incumbent must have experience in the manufacture of one or more medical products, including medical devices and nutritional products. Positions held should demonstrate experience in similar environment/industry.

  • Incumbent must demonstrate understanding of applicable US and Foreign regulatory requirements, standards, and corporate/divisional requirements for the health care industry and a general technical understanding of the business operations.

  • Additionally the individual must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation support and service.

  • The incumbent will interface with division management and multiple functions. Influence and visibility extend beyond the immediate organization.

  • Must have the ability to work across boundaries to negotiate solutions.

  • Excellent interpersonal, persuasive and oral/written communication skills are essential.

  • Responsible to provide executive summaries to management with assessments of the risk and recommendations for improvements of the auditing program.

Accountability/Scope/ Budget

  • Effective execution of managing the audit program indirectly supports Abbott marketing activities and Management of financial goals.

  • Maintaining a compliance position may result in fewer FDA inspections and the inspections have a more positive outcomes (I.E Fewer FDA Form 483s, Warning Letters etc.)

  • Effective performance helps to prevent regulatory vulnerabilities that could result in product quality and/or regulatory problems that can negatively affect Abbott’s worldwide image, performance of Abbott earnings and stock, and customer confidence and loyalty.

  • Early detection of issues through audits can lead to more cost effective corrections and prevention of future issues.

  • The identification/correction of deficiencies could avoid operational shutdowns, suspension of new product approvals and seizure of product.

  • Such actions, if not prevented, can result in a loss of business opportunities and can negatively impact the profitability of the company.

  • The incumbent is recognized as an experienced auditor with full understanding of business and compliance/auditing priorities.

  • Appropriate management consultation will be sought when policy decisions are involved in having a major impact to the site.

  • The incumbent defines opportunities, plans and assures the timely execution of these plans to improve compliance, compliance metrics and cycle times for the area.

JOB FAMILY:

Operations Quality

DIVISION:

ANSC Nutrition Supply Chain

LOCATION:

United States > Columbus : 2900 Easton Square Place

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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