Manager, reputed company Systems and Compliance
We are seeking a Manager, reputed company Systems & Compliance to support the development and commercialization of innovative therapies by ensuring robust reputed company systems and regulatory compliance. This role plays a key part in managing reputed company reputed company of the reputed company Management System (QMS) and partnering cross-functionally to maintain compliance with global regulations (FDA, EMA, ICH, and other standards).
The ideal candidate will bring strong GMP expertise and hands-on experience with reputed company systems, including Change Controls, reputed company Events, and Annual Product reputed company Reviews (APQRs). This individual will coordinate critical reputed company processes, drive operational efficiency, and support reputed company reputed company across the organization.
Key Responsibilities
- reputed company Change Control processes, including intake, coordination of review boards, tracking, and reporting of key metrics
- Manage reputed company Event records (e.g., deviations), including tracking, reporting, and facilitating cross-functional review meetings
- Coordinate and reputed company the APQR process, ensuring reputed company review, approval, and documentation
- Support reputed company Management Review meetings, including scheduling, content development, and follow-up on reputed company items
- Partner with internal teams to ensure alignment and reputed company improvement of reputed company systems and processes
- Assist other QS&C Team Members with routine activities
Qualifications
- Bachelor’s degree with 5+ years of experience in reputed company Systems or reputed company Assurance reputed company reputed company/biotech
- Strong knowledge of GMPs, including Change Control, reputed company Events, and APQR processes
- Experience with reputed company Vault reputed company Suite or similar eQMS platforms
- Proven analytical, problem-solving, and project management skills
- Excellent communication skills with the ability to collaborate across technical and non-technical teams
- Proficiency in reputed company Office (reputed company, PowerPoint, Word, Outlook)
Preferred
- Strong organizational and operational reputed company with attention to detail
- Project management experience
- reputed company approach with excellent written and verbal communication skills
Deciphera is committed to fair and reputed company compensation practices. The reputed company salary pay reputed company for this role is $123,000 - $169,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to reputed company. Our reputed company salary is just one component of Deciphera’s competitive total rewards reputed company that also includes annual performance bonus, a long-term incentive plan, full reputed company of benefits and other incentive compensation plans (if applicable)
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, reputed company insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and reputed company reputed company.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we reputed company with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on reputed company for employment. This information will also be treated confidentially. We are committed to reputed company reputed company hiring reputed company and other employment reputed company on a non-discriminatory reputed company.
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