Medical Quality Assurance

10 hours ago

Singapore Takeda Pharmaceutical Full time

Overview

Key Responsibilities
- Lead QA and governance for medical teams across GEM.
- Develop comprehensive regional and local plans in partnership with global QA and cross-functional stakeholders.
- Lead and provide guidance on country medical QA activities (including but not limited to medical affairs and GxP-regulated activities) by collaborating with regional and local level medical teams and cross-functional stakeholders.
- Lead review of existing medical processes and improvement for medical owned processes including global and cross-functional alignment.
- Ensure medical processes remain fit for purpose and value adding through continuous improvement like metric development, activities tracking and regular process reviews with stakeholders.
- Capability build and ensure country and regional medical teams are audit ready
- Drive development, review and approval of GEM medical affairs related SOPs and lead revision/updates as needed.
- Ensure QA gaps are identified and appropriately mitigated, support audits relevant to medical QA in the regional and local medical affairs office as appropriate.
- Lead corrective action/preventive action development as needed.
- Lead monitoring programs as deemed necessary.
- Responsible for internal training, tracking and reporting for regional oversight and management.

Qualification and Experience
- Minimum 5 years of experience in medical affairs, quality assurance or compliance in pharmaceutical industry.
- Experience in medical quality or governance at country or above country level preferred.
- Experience in medical governance process and procedural set ups and/or audit and formulation of CAPA plans preferred.
- Experience of collaborating with geographically disperse teams in a multicultural environment.
- Ability to partner with and influence stakeholders in a matrix organizational, quick to adapt to changing business needs.
- Excellent negotiation and communication skills.
- Highly organized, self-disciplined, and attentive to details
- Independent and self-driven with a positive work ethic
- Well versed in highly technical and scientific languages
- Fluent verbal and written English communication skills

**Locations**:
Singapore, Singapore

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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