AbbVie

Quality Compliance Specialist

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Sep 25, 2020
Ref
198058
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Envision working with energetic colleagues and inspirational leaders. Allergan is always striving to find top scientists/associates to work at our DSO sites in California. Be Bold and grow your manufacturing biopharmaceutical career with the pharmaceutical and medical device industry leader!

Quality Compliance Specialist- Biopharmaceutical/GMP - Irvine, CA

"I'm looking for a team player with experience in both GMP data integrity and quality risk management. If you want an exciting opportunity supporting multiple organizations and sites to jump start your path to a successful career and contribute to keeping patients safe and healthy, I would be very interested in receiving your resume. Let's discuss what you can bring to the team and what you aspire to do in the future."

*YOU ARE more than just a title, YOU ARE... responsible for the Biologics Quality Risk Management (QRM), Auditing and Data Integrity (DI) programs utilized by Drug Substances Operations. The scope of this responsibility includes DSO Facilities (BSL and BLI) and support organizations (GPT, Engineering, EH&S, etc.) This role will act as the liaison between DSO and Global Quality Organizations to assure compliance to company policy. This position assures DSO (BSL and BLI) meets worldwide MOH cGMP regulatory requirements for Quality Risk Management (QRM) and Data Integrity (DI).

YOU WILL:

Be a trusted and expert partner. Responsible for oversight and management of the Quality Risk management and Data Integrity compliance programs throughout the Allergan Drug Substance Organization (DSO), and Internal audit management, Regulatory body audits, and corporate audits as well as all GMP support functions. These activities include internal and external compliance systems, GMP, GCP and GLP evaluation, and managing corporate driven initiatives to assure DSO compliance and timely completion of projects. This position assists in the management of Quality Risk Management (QRM) and Data Integrity (DI) activities, updates procedures to meet corporate and cGMP requirements, and ensure closure of required records. This position assists in providing on-going QRM and DI training to DSO employees. This position supports continuous improvement activities within the DSO and assure compliances with all cGMP requirements.

Build bridges. Responsible for working with Business Technology for the creation and management of GMP Electronic System Data Lifecycle Management activities such as: Data Backup and Restore, Data Archiving and Migration. Ensure Electronic System availability by assuring performance of User Account Provisioning\Deprovisioning, User Access Periodic Reviews, Disaster Recovery Testing, and if needed, System Recovery. Provide subject matter expertise for change controls for data integrity, OS Updates\Patches, electronic systems requirements and data security. Maintain an Electronic Systems Administrator program to comply with the requirements of the FDA, EU and ISO 134852003, and other relevant regulatory bodies. Provide Electronic System Compliance expertise in the revision of AbbVie DI standards and to provide recommendations regarding DI training materials and:

  • Electronic System Compliance & Governance
  • Audit Trail Management & Review.
  • Electronic System Inventory Management
  • Support New Projects (Electronic Systems)

Develop and implement workflows. Quality Risk Management: Responsible for building teams, providing training and on-going guidance of employees. Create templates, procedures, assessments, protocols and other documentation for the QRM program. This position works with Allergan Corporate to assure appropriate resources are available and guidance's are implemented at the site level. This position provides hands on support throughout the organization to assures QRM activities are actively monitored, actions completed, and periodically re-evaluated. Provide support, expertise, and direction to AbbVie Biologics sites during regulatory audits and inspection. Develop strategies to ensure successful audit and inspection outcomes for QRM and DI. Provide SME input in terms of RCA, CAPA and Investigations.

Partnership for the future. This role will be involved in the implementation of the Internal audit program at DSO and Regulatory and corporate audits. This role will also plan and execute Compliance readiness plan as needed. Compliance planning and execution. This role will design and implement a plan to ensure complete compliance to cGMP and all regulatory requirements. The plan will ensure audit readiness and successful MOH outcomes for licensure for non-commercial site and inspection readiness for commercial site. You will work with our Biologics and Manufacturing groups at both Irvine and Campbell, CA.

Qualifications

YOU BRING:

  • BA / BS degree
  • Minimum of five (5) years' experience in a cGMP setting. Prior experience in both QRM and DI.
  • Strong user of Excel, BMS/SCADA, and IT systems
  • Prefer experience in a GMP regulated environment
  • Provide oversight and management of multiple programs with diverse capabilities and deliverables.
  • Must have strong collaborative skills and foster team success. Requires excellent negotiation skills, and experience working in a cross-functional environment.
  • Experience with Regulatory and Internal Inspections.
  • Solid knowledge of regulatory requirements for biopharmaceutical / pharmaceutical processing, cGMPs.


ABBVIE LEADERSHIP SKILLS:

  • Excellence Focused
  • Boundaryless Mindset
  • Open and Authentic
  • Strategic Foresight


PDN2

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.