Associate Director: External Quality Assurance x 2 - Ireland
Want to know company name or location? Company managed [?]
Posted on : 09 June 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- We currently have two Associate Director opportunities, the successful candidates will be responsible for the implementation of Quality Operations (Quality Assurance and Quality Control) policies and discharge all QO responsibilities supporting external parties/partners and alliances (EP’s) for manufacture, testing, packaging, storage, and distribution of sterile pharmaceutical products, API intermediates, API, non-sterile pharmaceutical products, biologics, drug delivery devices and consumer care products under the direction or on behalf of the Quality Operations Director or Executive Director.
- These activities include assuring that products are produced from approved processes in conformance to all applicable regulatory requirements and Company policies and may include the release of all manufactured products. The incumbent will exercise a leadership role in monitoring and maintaining the EP’s compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.
- The incumbent ensures the quality performance of EP’s through direct oversight, support and technical advice, counselling to the EP site senior leadership and providing on-site supervision as appropriate. This includes overseeing activities such as EP selection, GMP Due Diligence, and establishing Quality Agreements.
- The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the EP.
- This includes participating in end to end risk management and strategic initiatives related to compliant supply, operationalizing quality and developing an engaged and capable workforce within the extended external manufacturing organization.
- Responsibility for oversight of an EP involving releasing of the products to the market with the assurance that the goods were produced in conformance to all applicable policies and procedures of our company and compliance with all governing regulations.
- Responsibility for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied calibrated Quality oversight. These components may include review of batch documentation and deviation investigations.
- Incorporates strong risk management principles including special focus on data integrity at the EP and supports the end to end risk network risk management program (E2E) and the quality risk management (QRM) program.
- Assures the development and maintenance of a Quality Agreement with the EP. Provides input into the development of contractual agreements with the EP.
- Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the EP.
- Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities.
- Serves as an EQA and our Manufacturing Division subject matter expert in specific Quality systems, technology platforms, regulatory expectations and/or EP management. Utilizes this expertise to drive improved and compliant processes/systems for EQA and our Manufacturing Division.
- Reviews all audit outcomes pertaining to the EP and ensures appropriate and timely corrective actions are identified and implemented.
- Monitors efforts to improve the EP’s quality and reliability through ongoing oversight and formal communication programs and forums.
- Provides support to the EP’s to facilitate and validate new product introductions.
- Conducts quality due diligence assessments for pre-approval considerations of new EP’s or introduction of new products.
- Develops presentations for Quality Council meetings. Provides oversight for presentation content and may support issuance of minutes.
- Coordinates significant investigations including Fact Findings and product recalls as needed.
- May act as the regulatory compliance liaison on our company's behalf to interface with regulatory agencies.
- Build and maintain strong relationship with external parties, operations, technology and procurement.
- Closely collaborates with appropriate business and functional areas to conduct Tier meetings, Joint Steering Committee meetings and Business Review Meetings to achieve our Manufacturing Division and our company objectives.
- In addition to supporting the quality operations activities at the external partner, s/he will support the execution of Strategic Initiatives related to compliant supply, operationalizing quality and developing an engaged and capable workforce.
- BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred. Minimum of 7 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
- Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities.
- Possess strong compliance mindset, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation. Some level of contractual and financial awareness is required.
- Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Travel: Yes, 20 % of the Time
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