Compliance QA Specialist

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.

Envision working with energetic colleagues and inspirational leaders.  Abbvieis always striving to find top scientists/associates to work at our Drug Substance Organization (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 and develop and implement QA compliance program and coordinate PAI and site licensure activities.  The scope of this responsibility includes DSO Facilities and support organizations This role will act as the liaison between DSO and Global Quality Organizations to assure compliance to company policy.  This position assures DSO 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 providing on-going QRM and DI training to DSO employees.  This position will develop and implement a comprehensive QA compliance program and coordinate the site through PAI and licensure. 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. 

 

Develop and implement workflows.   

QA compliance program: Develop and implement a comprehensive compliance program for site licensure. Ensure all quality systems are in place and robust. Prepare the site for PAI and licensure activities. Perform internal audit of Quality and operations systems for compliance with MOH guidances and requirements.

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 provides hands on support throughout the organization to assures QRM activities are actively monitored, actions completed, and periodically re-evaluated.

Audit management: Provide support, expertise, and direction to AbbVie Biologics sites during regulatory audits and inspection. Develop strategies to ensure successful audit and inspection outcomes for Quality systems 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. 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

 

 

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.