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QA & RA Manager

Expired Job

Abbott Barceloneta , PR 00617

Posted 5 months ago

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.

Job Summary:

HAVE YOU EVER DREAM OF MAKING AN IMPACT ON THE WORLD?

How? Become a Quality Assurance and Regulatory Affairs Manager at Abbott Puerto Rico in San Juan

As Quality Assurance and Regulatory Affairs Manager you will be responsible for all of the regulatory and quality assurance functions for Abbott in Puerto Rico, USVI and the Caribbean. The position provides the commercial teams with direction on all regulatory, quality assurance and compliance matters through training, guidance and consulting. The position ensures compliance with appropriate laws and regulations through oversight, monitoring, auditing and implementation of the quality system. This person is the primary contact for regional and divisional QA and Regulatory.

HOW WILL YOU MAKE A DIFFERENCE?

  • Responsible for compliance with applicable Corporate and Divisional policies and procedures for Abbott in the Puerto Rico, USVI and the Caribbean.

  • Maintain quality systems that comply with Abbott and regulatory requirements and establish a quality audit program and continual improvement of the quality system.

o Training program and records

o Change control

o Documentation practices and record retention

o Change control process

o Insure SOPs are clearly defined and implemented.

  • Conduct management reviews to assure the affiliate quality system is suitable and effective and that resources are adequate.

o Quality audit

o Act as key affiliate contact for internal audits and

Regulatory inspections and communications.

  • Insure that all products and services meet customer, business and regulatory requirements.

o As applicable, manage customer complaints by

providing complaint reports to identified division contacts.

o Manage and elevate significant product events.

o Manage quality events including QA holds, product actions

and exceptions (Deviations, nonconformities).

o Define and implement corrective and preventive

actions (CAPA) addressing audit observations.

  • Works with 3rd Party Logistics company to insure compliance with all Abbott quality requirements and procedures.

o Verify and manage all product returns.

o Storage and distribution requirements.

  • Monitors and manages local regulations and has responsibility of product registration (provides advice, new

market entry product registration strategies) and other

regulatory programs.

  • Insure labeling and promotional material comply with Abbott requirements and applicable regulations.

  • Represent the affiliate regional /divisional and/or corporate teams, projects or issues as required.

  • Manage technical or service level agreements as necessary between quality system providers or guest organizations.

To be successful in this role, you will require the following qualifications :

  • Bachelors Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) or medical fields is preferred.

  • Minimum of 7 years work related experience with 3+ years experience in a regulated industry (e.g. medical or nutrition products) with experience in regulatory and quality assurance

  • Proven expertise as quality professional within FDA environment

  • Experience in a commercial environment is highly desirable.

  • Excellent communication skills in English and Spanish.

  • Proficient in MS Office (PP, Excel, Word)

  • Experience managing quality issues and provide & implement solutions.

  • Influencing skills and ability to work with diverse groups

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 or email


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QA & RA Manager

Expired Job

Abbott