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Foundation Academy Charter School Trenton, United StatesSummary · The Marketing and Communications Director at Foundation Academies leads Marketing strategy, internal and external communication strategies, fostering the organization's brand. Responsibilities include planning campaigns, supervising creative staff, analyzing engagement ...
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Foundation Academies Trenton, United StatesSummary · The Marketing and Communications Director at Foundation Academies leads Marketing strategy, internal and external communication strategies, fostering the organization's brand. Responsibilities include planning campaigns, supervising creative staff, analyzing engagement ...
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Senior Director - Trenton, United States - Enzene Biosciences
Description
We are looking for a Senior Director, Quality Assurance to lead our US Quality operations and ensure compliance with global regulatory standards and customer expectations.
You will be responsible for overseeing the quality systems, processes, and personnel at our state-of-the-art biopharmaceutical manufacturing facility in the US.
You will also be a key member of the senior leadership team, contributing to the strategic direction and growth of the company.
Location :
New Jersey
As the Senior Director, Quality Assurance, you will:
Establish and maintain a robust quality culture and foster a continuous improvement mindset across the organization.
Develop and implement quality strategies, policies, and procedures in alignment with corporate goals and industry best practices.
Manage and optimize the quality functions, including quality assurance, validation, and compliance.
Ensure the quality and safety of the products and services delivered to our customers, meeting or exceeding their requirements and expectations.
Lead and support the preparation, execution, and follow-up of internal and external audits and inspections by regulatory agencies, customers, and partners.
Monitor and report on key quality performance indicators and metrics, and initiate corrective and preventive actions as needed.Manage and develop the quality team, providing coaching, training, and career development opportunities.
Collaborate and communicate effectively with cross-functional teams, such as operations, engineering, R&D, business development, and senior management.
Stay abreast of the latest trends, developments, and regulations in the biopharmaceutical industry and ensure compliance with applicable standards and guidelines.
Key Deliverables includes, but not limited to:
Collaborating with a CQV vendor to successfully Commission, Qualify and Validate the facility that is ready to initiate PPQ runs.
Build a QA organization to support CDMO business.To be successful in this role, you will need:
A bachelor's degree or higher in life sciences, engineering, or related field.
A minimum of 15 years of experience in quality management in the biopharmaceutical industry, preferably in a CDMO environment.
A proven track record of leading and managing quality operations and teams in a fast-paced and dynamic setting.
A strong knowledge of GMP, GLP, GDP, and other relevant quality standards and regulations, such as FDA, EMA, ICH, etc.
A demonstrated ability to plan, execute, and oversee complex quality projects and initiatives, ensuring timely and successful completion.A high level of analytical, problem-solving, and decision-making skills, with a data-driven and risk-based approach.
A customer-oriented and results-driven mindset, with a focus on quality excellence and customer satisfaction.
A strong leadership and interpersonal skills, with the ability to influence, motivate, and inspire others.
An excellent oral and written communication skills, with the ability to communicate effectively with internal and external stakeholders at all levels.
A willingness and ability to travel domestically and internationally as required.#J-18808-Ljbffr
