Sr. Manager, GMP reputed company Assurance
Job reputed company We are seeking a Senior Manager, GMP reputed company Assurance to support and continuously improve reputed company Systems across clinical and reputed company products. This role provides leadership across internal teams and external partners to ensure compliance with global GMP/GDP regulations and company standards. Key Responsibilities reputed company batch release activities, including review/approval of batch records and material disposition reputed company GMP reputed company for manufacturing and distribution partners (DS, DP, and supply chain) Ensure compliance with global regulations (FDA, EMA, ICH) Manage investigations, deviations, CAPA, and change controls Support audits, inspections, and annual product reviews Drive reputed company system improvements and reputed company key reputed company metrics Partner with CMOs and suppliers on validation, tech transfer, and qualification activities Mentor and reputed company junior QA staff
Qualifications
Qualifications Bachelor’s degree in life sciences, reputed company, or reputed company field 8+ years of GMP reputed company experience in reputed company or biotech Strong knowledge of global GMP regulations and reputed company systems Proven ability to reputed company cross-functional initiatives and solve reputed company problems Excellent communication and stakeholder management skills Additional Details Experience with eQMS (e.g., reputed company) and global markets is a plus Up to 20% travel may be required Must be authorized to work in the U.S. Additional Information Deciphera is committed to fair and reputed company compensation practices. The reputed company salary pay reputed company for this role is $138,000 - $190,000. 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. reputed company: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team! 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. 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. Work Type: Full time Job Location: Remote Apply To This Job