Head/Senior Director, Quality

Foresee Pharmaceuticals Co., Ltd. (Foresee) strives to improve patients' quality of life and provide cures through innovative research. Foresee is committed to applying the highest ethical standards to our products, services and communications. Foresee is developing and commercializing new drugs using its proprietary drug delivery technology as well as developing first-in-class new chemical entities in disease areas of high unmet medical needs.

The Head/Senior Director of Quality at Foresee will provide leadership, organization, and monitoring for GxP compliance. The Head/Sr. Director of Quality Assurance is accountable for ensuring full quality and regulatory compliance of the company and its vendors. The Head/Sr. Director will supervise and provide leadership and direction to Quality assurance staff.

Responsibilities will include:

-       Develop and maintain multi-party quality and QP/QP agreements with Foresee’s CDMOs and other partners in a manner that meets both GxP requirements and business needs.

-       Develop and lead the quality function to comply with FDA, EMA and ICH GXP regulations and guidelines as a part of all company practices and procedures.

-       Manage an internal team of Quality professionals as well as external consultants as necessary.

-       Develop policies and procedures for monitoring compliance. Assess and mitigate potential risks.

-       Develop, implement, and maintain a risk management program appropriate to the company’s strategies.

-       Participate in Risk Assessment and Mitigation evaluation activities.

-       Responsible for vendor compliance audits, site qualification audits, and internal audits.

-       Establish and maintain the core value of ‘Data Integrity’, and design resources and training across the company to support this value.

-       Develop and maintain a Quality Management System (QMS).

-       Oversee all Quality related communications and training requirements for all company employees.

-       Review records (e.g., manufacturing batch records, release & stability testing data, SOPs, Deviations, Change Requests, and Corrective and Preventative Action (CAPA) reports).

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Qualifications:

• Experience with quality assurance aspects of all stages of drug development, including clinical, registration, and commercial.

• At least a bachelor’s degree and 12-15 years’ experience in an FDA-regulated quality assurance or compliance role including 5 years of management experience is preferred.

• Knowledge and experience in the application of laws, regulations, and guidance documents related to FDA and global requirements (biologics, pharmaceuticals, devices, etc.).

• Previous experience with FDA GMPs and EU regulations. Additional experience with other international regulations is preferred.

• Experienced in managing project teams and working cross-functionally at a global level.

• Demonstrated collaboration, negotiation & conflict resolution skills, demonstrated expertise to effectively communicate within all levels of the organization.

• Ability to manage tasks independently and make independent quality decisions.

• Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.

• Ability to read and write fluently in French is desirable but not required.

• Ability to travel to perform/support audits as needed.

The salary and benefits for this role are very competitive and include stock options.Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.