Forest Laboratories, Inc. (FLI)
is an innovative, growth-oriented prescription pharmaceutical company focused on developing top-quality therapies that help people lead healthier, more fulfilling lives. We take pride in meeting our business objectives and expanding our product franchises, but we also derive satisfaction in helping to bring relief to people who are suffering. Our products treat conditions such as depression, anxiety, Alzheimer’s disease, hypertension and fibromyalgia, and we keep a focused eye on the future with a robust pipeline of compounds at virtually every stage of development. With headquarters in New York City and operations in New Jersey, Long Island, Missouri, Ohio, California, Ireland and the U.K, each of Forest’s more than 5,000 employees contributes to our quest to deliver quality products with entrepreneurial spirit, unflagging integrity and deep respect for people and community. Explore your potential to thrive with a career at Forest.
The Executive Director- Quality Control is a senior member of the Corporate Quality & Compliance organization. This position is responsible for providing leadership and direction to the wider Quality Control organization ensuring company-wide effective, efficient and compliant operations, harmonizing laboratory practices across the sites, setting expected global standards for same and introducing organization wide electronic systems to support the needs of the QC organization and the business in a global environment. Additionally, the Executive Director- QC is responsible for all aspects of the Quality Control laboratories operations within Forest and leading the development and implementation of the overall compliance policies and procedures of the Quality organization. This position reports to the Vice President- Corporate Quality & Compliance and may reside in Farmingdale, NY or Dublin, Ireland.
Main areas of responsibility:
- Provide leadership and direction to the QC operation at Forest Laboratories Inc. to support the wider supply chain operation and to ensure it meets its commitments to its customers, while complying with regulatory requirements.
- Develop the organization such that it is responsive, flexible and adaptable to future challenges. Ensure the timely deployment and implementation of global projects that support flexibility, adaptability and efficiency goals.
- Represent the Quality Control function to all internal and external stakeholders. This includes the global QC organization, FPI and Corporate senior executives, all internal and external partners, as well as FDA and other regulatory agencies.
- Ensure QC organization involvement in validation/qualification/calibration/technology transfer projects
- Prepare, submit and defend QC organization budgets including headcount, expenses, capital and training.
- Prepare, submit and defend QC organization capital projects to improve laboratory operations and supply chain support.
- Maintain technical and regulatory knowledge and ensure information is disseminated across QC organization.
- Provide formal and informal performance feedback to direct and indirect reports across QC organization including YE performance and compensation.
- Cascade overall QC functional goals and objectives consistent with Forest corporate goals and strategy, develop plans to achieve those goals and prioritize and execute those plans.
- Coordinate the review of regulatory submission documentation from the QC organization perspective
- Provide leadership for the compendial interactions (USP, EP, etc.) and assure QC methods and specifications are compliant to compendial requirements.
Minimum Qualifications to be considered for this position:
Ideally candidates will also have:
- Bachelor’s degree in Chemistry or related scientific field.
- 10+ years total experience in a GMP laboratory environment.
- 7+ years of experience in supervision of technical personnel in a GMP environment.
- Experience leading a multi-location QC organization within a global environment.
- Excellent working knowledge of FDA, EU and other regulations.
- Strong technical knowledge of analytical techniques and instrumentation.
- Excellent working knowledge of computerized laboratory systems.
- Excellent working knowledge of pharmaceutical product manufacturing techniques.
- Ability to work in a multidiscipline team but also possesses self-motivation and drive.
- Maturity to accept responsibility for resolving difficult situations in a professional manner.
- Ability to handle the ambiguity inherent in a matrix reporting relationship.
- Oral and written communication skills in order to be able to tactfully communicate with regulatory agencies and senior management.
- Demonstrated ability to effectively lead other staff members in a team environment and drive results from others, while ensuring corporate strategy, goals, and objectives are met.
- Master’s degree in Chemistry or related scientific field.
Forest Laboratories doesn't just blend in with the trees. The company develops and manufactures prescription drugs to address a wide...