Manager Quality Assurance GCP and GLP

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

Career development with an international company where you can grow the career you dream of.

Benefits such as Medical and Dental Assistance, Life Insurance, Private Pension Plan, Medication Subsidy, Discount on Abbott stock purchases, among others.

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

We offer flexible work policies that allow a healthy balance between personal and professional life

We invest in the development of our employees through training andgrowth opportunities

We foster an environment where every voice is heard and valued

The Opportunity

This position works out of our São Paulo site in the Pharmaceutical Division.

As the Manager Quality Assurance GCP and GLP is responsible for ensuring compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations throughout the pre-clinical and clinical development phases and at qualified service providers.

What You’ll Do
•    Ensures execution of audits, management of deviations and Corrective and Preventive actions, and supports continuous improvement initiatives.
•    Provides advice and support for the quality and compliance of the clinical and pre-clinical processes to be in line with the strategy of the Division and the objectives of the Clinical Governance Boards and clinical project teams.
•    Implements the strategy for embedding Good Clinical Practice within Clinical by acting as Subject Matter Expert and supports key quality projects.
Core Job Responsibilities:
•    Representing QA GCP in clinical study teams and monitoring clinical studies throughout its entire lifecycle.
•    Preparing and supporting the creation of quality documents for Clinical studies including study specific QA plans based on risk assessment, Protocol, Clinical Study Reports, agreements and Investigations Medicinal Product labels.
•    Creating and maintaining an GCP and GLP audit schedule.
•    Leading and conducting study audits, such as Investigator site audits, Trial Master File audits, Data Management audits, Phase I-IV studies and Bioequivalence and Bioavailability studies and Clinical Study Report audits. 
•    Leading and conducting audits of service providers involved in the conduct of Pre-clinical and Clinical studies, such as Central Laboratories, Clinical Trial supplies, Monitoring, Translation, and Archival service providers.
•    Conducting internal system and process audits of Clinical.
•    Leading inspection readiness activities by preparing internal staff and coordinating with service provider personnel to ensure the availability of relevant information, data, and explanations during GCP Health Authority inspections, and internal system audits.
•    Ensuring Quality support during Health Authority inspections conducted at service providers, including resource planning, outcome evaluation, response approval, and oversight of Corrective and Preventive actions.
•    Providing advice and training on QA GCP and GLP topics for internal, cross-functional teams. 
•    Providing QA oversight on regulatory environment for GCP (pharmaceutical products).
•    Advising and contributing to investigations in case of significant events. 
•    Reporting of GCP metrics of quality system and compliance data.

Required Qualifications

Minimum Education:
•    Master’s degree in a life science-related discipline or equivalent level of education in a relevant scientific/ technical discipline such as Chemistry, Pharmacy, Biology, Microbiology, Engineering or industry experience with sufficient exposure to pharmaceutical industry.

Minimum Experience/Training Required:
•    At least 10 years in the pharmaceutical industry of which a minimum of 7 years’ quality systems leadership in highly regulated environment
•    At least 5 years in clinical / pre-clinical research leading function or GCP Quality Assurance 
•    Extensive knowledge of international and local quality system and compliance legislations and standards
•    Good communication and consultancy skills, decisive, hands-on mentality, strong interpersonal skills
•    Able to manage effectively relevant topics with various interfaces including Health Authorities (Inspectors, Regulatory bodies)
•    Analytical and strategic thinking, risk-based thinking, flexibility, problem-solving 
•    Good command of the English and Spanish language, both spoken and written.

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

Brazil > Sao Paulo : Building 1

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 20 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable