Senior Manager, Clinical Quality Assurance

Company Description

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 and our European operations are run out of Switzerland. 

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

• Draft, review, revise or provide input to GCP/GLP/GVP SOPs to assess consistency and compliance with regulatory requirements/internal standards
• Attend cross-functional team meetings and provide guidance to GCP/GLP/GVP functional groups based on interpretation of current regulations to ensure best practices including risk-based management
• Work closely with GCP/GLP/GVP functional groups to ensure/coordinate appropriate and complete resolution of findings/non-compliances, deviations, investigations, CAPAs in a timely manner, including oversight and approval of all abovementioned activities, as necessary.
• Assist and participate in various audits (e.g. clinical site audits, vendors, internal systems), as needed
• Work directly with third party vendors and contractors, managing effective chain of communication related to GCP/GLP/GVP compliance
• Interact with contract auditors facilitating scheduling audits, conducting pre-audit meetings, drafting audit plans, agendas, audit reports, and confirmation letters as appropriate
• Oversee the audit response process and ensure acceptability of actions addressing findings fetched during the various audits.
• Provide QA review of various procedures, clinical protocols, investigators brochure, clinical study reports and pharmacovigilance system management files and other relevant documents as needed
• Escalate issues of critical and major non-compliances and/or lack of urgency in remediation as appropriate
• Participate and/or conduct independent root cause analysis of various deviations and/or quality issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements
• Assist with inspection readiness, and participate in regulatory inspections as needed

Qualifications

• At least 5 years of direct GCP pharmaceutical/biotechnology experience
• Solid understanding and application of GCP/GVP guidelines and regulations. 
• A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
• Excellent interpersonal skills with solid knowledge of negotiation and conflict management skills to assure effective interactions with internal and external stakeholders
• The ability to handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Ideal candidate will have broad experience in GCP/GVP environments (particularly in post-marketing PV activities), regulatory compliance and solid experience in GCP/GVP field auditing
• Experience with using risk-based principles & decision making to ensure ongoing compliance at all stages of product development

Additional Information

What Deciphera will Bring: 

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes the following: 

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• 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
• ESPP offering
• Health savings account with company contribution
• Flexible spending account for either health care and/or dependent care.
• Family planning benefit
• Generous parental leave
• [if applicable] Car allowance

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.