Associate Director Quality Assurance

2 weeks ago

Dublin, Dublin City, Ireland AbbVie Full time

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us . Follow @abbvie onX ,Facebook ,Instagram ,YouTube andLinkedIn .

Job Description

We are now hiring a Quality assurance Associate Director on our AbbVie Dublin site in Clonshaugh for a 23 month contract.

The Quality Assurance Associate Director manages the Quality Systems and Design group within the Quality Assurance Department at AbbVie Ireland Clonshaugh and is responsible for developing, implementing and maintaining site compliance strategies and Quality Systems. The Associate Director is responsible for staying current with proposed and implemented regulations and understanding industry trends. This position interfaces and collaborates with corporate and other site management in assuring that AbbVie Ireland Clonshaugh is fully compliant with HPRA, FDA and corporate standards. The Associate Director is responsible for transitioning developmental products into AbbVie Ireland Clonshaugh Quality Systems and overseeing compliance for the site manufacturing and supply chain operation. The Associate Director is an expert in current Good Manufacturing Practices and manages many of the site key Quality Systems. The Associate Director is a key participant in site regulatory agency inspections. This position supervises a team of QA Technicians and reports to the Director, Quality for the site.

Responsibilities:

  • Provide strategic and tactical direction for Quality Systems design and maintenance.
  • Manage key site quality systems such as Change Control, Deviations, CAPAs, Product Quality Reviews, Internal Auditing, Site Quality Reviews, Document Management and Control, Labeling Artwork Approval, Technical Agreements and Site Master File. Measure and report site performance on key indicators of these quality systems through metrics.
  • Ensure quality system performance is appropriately and well communicated throughout site. Provide guidance and assessments on other site Quality Systems.
  • Ensure site applicable aspects of regulatory submissions are appropriately reviewed for consistency between site procedures and methods and regulatory submissions.
  • Ensure site compliance with HPRA, U.S. Food and Drug Administration and other regulatory authority regulations, as appropriate.
  • Lead and direct critical out-of-specification (OOS) and deviation investigations.
  • Develop and sustain a culture of constant site readiness for site inspections. Identify industry trends and implementation strategies to keep the site ahead of the compliance curve and within AbbVie's budgetary requirements.
  • Develop a support/service mentality in Quality staff, partnering with local site departments.
  • Serve as a key participant in site regulatory agency inspections.
  • Support daily activities, ensuring QA personnel execute their work in strict accordance with SOPs, and cGMP guidelines.
  • Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations. This includes building staff capability by providing ongoing coaching and mentoring of direct reports, providing timely recognition as well as performance counseling, building and executing development plans, and providing career counseling for career progression.
  • Maintain accountability for own team's performance metrics that support the annual operating plan and site strategic plan objectives.
  • Provide hands on training, support, and coaching to reports and make timely decisions to ensure that performance Service Level Agreements (SLAs) can be met.
  • Enforce cGMP, safety, housekeeping, and security procedures, maintaining a safe working environment and promptly reporting incidents and accidents to site leadership.
Qualifications
  • Bachelor's Degree or above in Chemistry, Pharmacy or related Science.
  • At least 5 - 7 years relevant Pharmaceutical Quality experience and 3-5 years supervisory experience. This experience does not have to be limited to Quality Assurance.
  • Must have excellent understanding of current Good Manufacturing Practices and manufacturing operations
  • Demonstrated success in managing a team in a pharmaceutical production environment and providing leadership in a technical environment
  • Experienced and knowledgeable in EU and FDA cGMPs
  • Experienced in interacting with regulatory authority inspectors
  • Experience in managing by metrics
  • Experienced in aligning individuals and teams to business objectives
  • Exposure to Lean manufacturing concepts
Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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