Director of Quality Assurance

1 day ago


Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time
Job Description

Deciphera Pharmaceuticals is seeking a highly skilled and experienced professional to join our team as a Director of GMP Quality. This is a critical role that will be responsible for ensuring the quality and compliance of our products.

Key Responsibilities
  • Ensure compliance with 21 CFR 210/211, 312, EudraLex Vol. 4, and ICH regulations.
  • Provide GMP oversight and management of quality-related tasks and priorities of clinical and commercial vendors/partners.
  • Develop and execute continuous QA improvements.
  • Provide guidance, development, and leadership to the 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 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.
  • Hire/Manage QA employees.
Requirements
  • 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 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.
  • Ability to travel ~10% domestically and internationally.
  • Must be authorized to work in the US.


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