シミックグループは日本初のCRO（Contract Research Organization：医薬品開発受託機関）として、自由な発想と先見性で、医薬の世界に新たなサービスを生み出してきました。現在では医薬品開発だけでなく、製造、販売まで、製薬企業の全てのプロセスを支援するサービスを提供しています。30周年を迎えた現在、個人のヘルスバリューを高めるために新たな挑戦のステージに入っています。従来のビジネスを武器に事業拡大していく中で、グループ横断的に様々なプロジェクトやタスクが複数開始される予定です。
The Associate Director, Quality Compliance is responsible for supporting the Expert (SME) standpoint in accordance with CMIC policies, standards, procedures, and cGMP. Functional responsibilities for the incumbent include performing approvals for manufacturing investigations, driving proactive and corrective improvements within Operations, managing the internal inspection readiness program, providing support at all regulatory inspections and corporate audits, tracking internal/external audit commitments and driving on time closure, evaluation of new requirements and emerging regulations, and oversight for trending of quality compliance.
- Develop, improve, and monitor Quality Systems within the organization.
- Manage the eQMS and training program (LMS in eQMS).
- Review and approve manufacturing investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
- Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
- Ensure control of systems, processes and product through supporting review and approval of change control and validation.
- Responsible for complaint management
- Responsible for Batch Review, Product release, and Record archiving.
- Review site change controls and ensures appropriate requirements are identified and completed for implementation to ensure continuous improvements
- Responsible for scheduling and execution of the site internal auditing program assuring CAPAs are completed in a timely manner.
- Develop, improve, and monitor supplier management program.
- Monitor and track external audit/inspection commitments to ensure timely closure.
- Assess standards/policies and emerging regulations.
- Write, revise, and approve standard operating procedures (SOPs)
- Responsible for issuing site metrics for compliance and adherence to corporate requirements.
- Manages Annual Product Review
- Direct quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
- Is recognized as the Subject Matter Expert within the group.
- Provide guidance to other employees in interpretation of complex data.
- Routinely recognizes Quality issues and solves problems.
- Proposes solutions for complex issues and works with management to resolve.
- Follows established procedures and performs work as assigned.
- Builds relationships internally within and with cross-functional teams.
- Contributes to goals within the work group.
- Bachelor's degree in Biology, Chemistry, or similar field.
- At least 10 years’ of experience in Quality Assurance / Compliance in the pharmaceutical or related industry.
- Strong Knowledge of cGMP (21CFR 11, 210 & 211), Investigations/Deviations, CAPAs, Change Controls, SOPs, Complaints, and APRs.
- Experience creating and presenting Metrics is required.
- GMP Auditing experience is a plus.
Experience and Skills
- Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
- Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
- Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
- Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across a majority of the job function.
- Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
- Must be skilled in planning and organizing, decision-making, and building relationships.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
- Capable of providing input within the department and cross-functional teams.
- Able to recognize conflict and notify management with proposed recommendations for resolution.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to write and review reports with clarity and brevity.
- Thorough knowledge of and competence in quality processes, including but not limited to material disposition, change control, product complaints, deviations, investigations, validation, supplier management, and CAPA management.
- Knowledge of US and global cGMP requirements.
- Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
- Ability to make independent and objective decisions and to work with minimal supervision.
Interested parties please apply via email
Responsible Person Contact details
Name: Nancy Barr
|職種 / 募集ポジション||Associate Director Quality Compliance※CMIC CMO USA|
|会社名||シミックホールディングス株式会社／CMIC HOLDINGS Co., Ltd. (HQ)|
|創業 / Foundation|| |
1992年（会社設立：1985年3月14日) In 1992 (The Company was established on March 14, 1985)
|代表者 / Representative Directors|| |
代表取締役CEO 中村 和男 / Kazuo Nakamura, Chairman and CEO 代表取締役COO 大石 圭子 / Keiko Oishi, President and COO
|従業員数 / No.of Employees|| |
7,878名（連結子会社含む）※2022年5月現在 7,878 (as of April 1, 2022 on a consolidated basis)