Deciphera Pharmaceuticals, Inc
Director, GMP Quality
Deciphera Pharmaceuticals, Inc, Waltham, Massachusetts, United States, 02254
Deciphera 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.In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Australia, Canada, China, and Hong Kong.Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas.We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:Patients
– places the importance of improving the lives of patients and their caregivers at the forefront of every day’s work.Accountability
– for our performance and the way we work with coworkers and other stakeholders.Transparency
– in our intent and actions to both internal and external stakeholders.Honesty and Integrity
– fosters trust and strives to deliver on our and the company’s promises.Stewardship
– values and uses wisely the resources and investments provided to the company.Job Description
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 quality related tasks and priorities of clinical and commercial vendors/partners.Develop and execute on continuous QA improvements.Provide guidance, development and leadership to GMP QA department.Responsible for all material disposition.Review and Approve Master Batch Production & Packaging Records and Executed Batch Production & Packaging Records.Review and approve analytical data (release data, specifications, stability, etc.)Collaborate and support with internal stakeholders, partners on validation and technology transfer activities.Establish and maintain strategic business partnerships to ensure corporate deliverables are met.Support internal audit program and regulatory inspections.Lead Clinical QP release activities.Review pertinent CMC sections of regulatory submissions.Qualifications
B.S. degree in life sciences, chemistry or equivalent.10+ years of GMP Quality experience, with at least 5 years managing experience.Ability to manage multiple projects in a dynamic environment.Experience working with solid oral dosage forms.A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.Excellent interpersonal skill 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.Ability to travel ~10% domestically and internationally.Must be authorized to work in the US.Additional Information
All your information will be kept confidential according to EEO guidelines.EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera 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.
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– places the importance of improving the lives of patients and their caregivers at the forefront of every day’s work.Accountability
– for our performance and the way we work with coworkers and other stakeholders.Transparency
– in our intent and actions to both internal and external stakeholders.Honesty and Integrity
– fosters trust and strives to deliver on our and the company’s promises.Stewardship
– values and uses wisely the resources and investments provided to the company.Job Description
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 quality related tasks and priorities of clinical and commercial vendors/partners.Develop and execute on continuous QA improvements.Provide guidance, development and leadership to GMP QA department.Responsible for all material disposition.Review and Approve Master Batch Production & Packaging Records and Executed Batch Production & Packaging Records.Review and approve analytical data (release data, specifications, stability, etc.)Collaborate and support with internal stakeholders, partners on validation and technology transfer activities.Establish and maintain strategic business partnerships to ensure corporate deliverables are met.Support internal audit program and regulatory inspections.Lead Clinical QP release activities.Review pertinent CMC sections of regulatory submissions.Qualifications
B.S. degree in life sciences, chemistry or equivalent.10+ years of GMP Quality experience, with at least 5 years managing experience.Ability to manage multiple projects in a dynamic environment.Experience working with solid oral dosage forms.A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.Excellent interpersonal skill 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.Ability to travel ~10% domestically and internationally.Must be authorized to work in the US.Additional Information
All your information will be kept confidential according to EEO guidelines.EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera 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.
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