Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a dynamic, highly motivated, experienced individual for the position of Associate Director, GMP Quality. The position reports to the Director, GMP Quality Assurance. The location of the position is in Brisbane, CA.
This position will be responsible for managing quality and compliance related to GMP operations for clinical and commercial drug substance manufactured and tested at Contract Service Providers (CSPs). S/he is accountable for managing and driving investigations, deviations, complaints, escalation, change control, activities associated with MRB and regulatory actions related to drug substance, including drug product, when required. Assist with the maintenance of the various quality system procedures and policies to ensure compliance with the current regulations and all applicable regulatory requirements.
Essential Duties and Responsibilities
- Oversee batch record review and perform batch disposition for drug substance and/or drug product (for further processing), when required.
- Evaluate, review and approve CSP and Myovant change controls, GMP investigations and deviations.
- Author deviations, change controls, risk assessments, product complaint investigations related to QA operations/systems
- Manage assigned activities related to partners/business alliances
- Development and maintenance of Quality Agreements with CSPs.
- Review and approve master batch records, risk assessments, technical and validation protocols and reports.
- Support CMC activities for the Pharmaceutical Operations and Development Department including supporting review of regulatory submissions.
- Conduct and support CSP audits as needed, gathering quality KPIs, supporting and/or participating in business review meetings, quality management review, and escalations as required.
- Revise and/or author/implement procedures to support QA operations.
- Assist in preparation of Health Authority Inspections, including follow-up efforts, to ensure successful outcomes.
- Partner with external and internal partners to ensure Corrective and Preventative Action Plans (CAPA) to address findings from incident investigations, audits or Health Authority Inspections are appropriate and effective.
- Maintain current knowledge and full understanding of compliance and regulatory requirements (FDA, EMA, MHRA, etc.) related to the manufacture of active pharmaceutical ingredients and drug products.
- Promote collaboration internally and with external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
- Coach and develop QA operations staff.
- Other duties as assigned.
Core Competencies, Knowledge, and Skill Requirements
- Strong working knowledge of FDA regulations (21CFR4, 210/211), ICH guidelines, and global regulations (EU Directives, and ROW) and expertise in the cGMP requirements pertaining to manufacturing operations in the United States and globally in support of global clinical and commercial production activities.
- Demonstrate working knowledge of quality assurance systems, methods and procedures.
- Experience in audits, PAI and PAI readiness activities.
- Experience with Quality Risk Management principles
- Demonstrate coaching skill to develop team
- Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make quality decision based on risk management and appropriate for the organization
- Results-driven, take initiative and ownership to accomplish work
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
- Bachelor’s degree required; advanced degree preferred.
- Minimum of 10+ years of direct experience in Quality Assurance operation and management roles in a current Good Manufacturing Practices (cGMP) environment within pharmaceutical or biotechnology industry Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
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Equal Employment Opportunity