The Forest Research Institute (FRI)-a wholly-owned subsidiary of Forest Laboratories, Inc.-drives the scientific research and development behind Forest's top-quality therapies that help people lead healthier, more fulfilling lives. With operations in Jersey City, NJ and on Long Island, plus clinical trial personnel across the country, the Institute's highly skilled professionals enable Forest to license compounds at virtually any stage¿from preclinical development to products that are ready for FDA review¿and then complete the development and regulatory work to successfully bring vital new therapies to market. Each of Forest's more than 5,000 employees¿including our 1,000 person strong Research Institute¿contributes to our quest to deliver quality products with entrepreneurial spirit, integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest.
Our Jersey City, NJ office has an exciting opportunity available as a Director- Quality Assurance.
This position is the leadership of GxP Quality Assurance and Compliance activities and ensures that QA activities support the acquisition, implementation, and maintenance of FDA regulated computer systems within Forest Laboratories Inc.
Duties and Responsibilities
* Work with various business partners to coordinate QA activities that support the validation of computer systems in accordance project schedules and business objectives.
* Ensure that validation standards and processes defined by Forest's Informatics function meet current FDA and industry standards.
* Provide Quality Assurance oversight on Computer System Validation projects to assure compliance with company standards, standard operating procedures, policies, industry best practices, and current FDA requirements utilizing a risk based approach.
* Ensure that Informatics QA computer system validation activities are being performed and documented in a timely and consistent manner.
* Establish Informatics QA expectations that promote proactive support for Computer System Validation and Compliance. Including participation in project team meetings and advising on quality assurance and compliance issues.
* Work with all teams within Corporate Quality and Compliance function to ensure that QA Informatics priorities and activities are appropriately aligned with broader QA strategies.
* Define, implement and maintain Informatics QA procedures and processes.
* Manage of Informatics QA personnel.
* Manage the preparation and execution of internal audits for periodic system reviews and test of controls.
* Partner with other business functions to develop, implement, and maintain quality systems.
* Support internal/external non-project initiatives.
* Bachelor's degree in Computer Science or related discipline.
* 10+ years Quality Assurance / Computer System Validation experience in the pharmaceutical or other FDA regulated industry.
* 4+ years of experience in the direct management and supervision of personnel.
* In depth knowledge of System Development Life Cycle, Computer System Validation, 21 CFR Part 11, current GxP Regulations, GAMP, Auditing, and SOP development.
* Experience with R&D and/or Manufacturing computer systems.
* Experience with Risk Assessment techniques.
* Excellent written and verbal communication skills.
* Ability to effectively interact within a team environment.
* Proven experience in dealing with change management
Forest offers a competitive salary and comprehensive benefits plan including medical, dental, and life insurance. Our benefits also include profit sharing and 401(k) plans, short-term disability and educational assistance and many other great benefits.
All job seekers must apply online at www.frx.com/careers.
Forest Laboratories, Inc. is an Equal Opportunity Employer.
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