Senior Manager, Clinical Program Quality
Takeda
full-time
Posted on:
Location Type: Remote
Location: Remote • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $137,000 - $215,270 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Provide expert GCP compliance guidance, training, and recommendations to program teams and leadership.
- Develop, implement, and manage risk-based audit strategies and conduct complex audits in line with GCP and Takeda policies.
- Assess and escalate compliance risks impacting subject safety, data integrity, or business operations to management.
- Ensure completion of timely audit reports and corrective actions, tracking effectiveness and regulatory reporting as needed.
- Lead investigations into significant quality issues and GCP breaches, ensuring root cause analysis and effective corrective actions.
- Support and manage GCP health authority inspections, guiding teams in preparation, response, and follow-up activities.
- Collaborate with Quality teams to identify, analyze, and address GCP compliance issues and present key metrics and recommendations to management.
Requirements
- Bachelor’s degree required; advanced degree preferred.
- At least 7 years of experience in pharma, biotech, or related healthcare industries.
- Minimum 5 years in GCP Quality Assurance or relevant clinical trial roles.
- In-depth knowledge of ICH GCP R2 and global clinical regulations.
- Advanced auditing expertise, including translating findings into risk-mitigating action plans.
- Excellent communication, technical writing, negotiation, and teamwork skills.
- Strong analytical abilities, sound judgment, and effective project management under tight timelines.
Benefits
- U.S. based employees may be eligible for short-term and/or long-term incentives.
- U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCP compliancerisk-based audit strategiesaudit reportingroot cause analysisGCP health authority inspectionsICH GCP R2clinical regulationsauditing expertiseproject management
Soft skills
communicationtechnical writingnegotiationteamworkanalytical abilitiessound judgment