Associate Director, GMP QA (Drug Substance, Drug ...

Full-time Work Type: Full time Job Location: On-Site Waltham Company Description Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera's switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116. We offer an outstanding culture and opportunity for personal and professional growth guided by our "PATHS" Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune's Best Places to Work Small and Midsized Biotech Companies in 2023. Job Description We are seeking an Associate Director to provide GMP/GDP QA expertise for the development and commercialization of Deciphera's products in compliance with relevant US, EU and ICH requirements. The primary responsibility of this position will be to ensure proper QA oversight and collaboration with Deciphera's Drug Substance (DS) Drug Product (DP) and Distribution vendors. This position will report to the Sr. Director, GMP Quality Assurance and be located in the Waltham, MA office. What You'll Do: Assure compliance (internally and externally) with 21 CFR 210/211, 312, EudraLex Vol. 4 (including relevant parts and annexes) and ICH. Provide GMP oversight and management of daily quality related tasks and priorities of the clinical and commercial DS, DP and distribution vendors. Review and approve Master Batch Production Records and Executed Batch Production Records. Responsible for clinical and/or commercial DS and DP material disposition and final distribution. Collaborate with internal functional area experts, as well as DS and DP vendors, to oversee, conduct and provide guidance on GMP manufacturing and testing investigations. Internal Quality lead for DS and DP partner change controls. Collaborate with and support internal stakeholders, along with DS and DP partners on validation and technology transfer activities. Establish and maintain strategic business partnerships to ensure corporate deliverables are met. Create and/or revise organizational procedures and processes for clinical and commercial programs. Develop, review and negotiate relevant Technical Quality Agreements with Deciphera's vendors. Assist in internal/external audit program and support regulatory inspections. Coordinate the authoring and compilation of Annual Product Reviews. Support authoring and review of clinical and commercial Regulatory filings. Support QP release activities. Manage and mentor junior team members. Qualifications What You'll Bring: B.S. degree in life sciences, chemistry or equivalent. 10+ years of GMP Quality experience, with at least 3 years managing external partners. Experience working with small molecule drug products. Ability to manage multiple projects in a dynamic environment. A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties. Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments. A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations and business needs. Proven track-record of leadership and building relationships with internal and external partners. Experience with using risk-based principles and decision making to ensure compliance at all stages of development. Experience with Veeva or similar eQMS, preferred. Ability to travel ~15% domestically and internationally. Must be authorized to work in the US. Additional Information Deciphera offers a comprehensive benefits package that includes but is not limited to the following: Non-accrual paid time off Summer vacation bonus Global, company-wide summer and winter shutdowns Monthly cell phone stipend Internal rewards and recognition program Medical, Dental, and Vision Insurance 401(k) retirement plan with company match Life and Supplemental life insurance for family Short and Long Term Disability insurance Health savings account with company contribution Flexible spending account for either health care and/or dependent care. Family planning benefit Generous parental leave Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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 your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis. #J-18808-Ljbffr

Created: 2024-11-11