Manager, Clinical Quality Assurance

2 weeks ago

Watertown, United States CareerBuilder Full time

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.
Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Decipheras first FDA approved switch control kinase inhibitor developed for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. QINLOCK is approved for 4th line GIST in the United States, Australia, Canada, China, Hong Kong, Switzerland, and Taiwan.
We offer an outstanding culture and opportunity for personal and professional growth based on our PATHS Core Values:
Patients We are committed to improving the lives of patients living with cancer. They are the driving force behind everything we do.
Accountability We demand accountability for our actions, behaviors, and performance. We recognize our duty to maintain a culture that embraces the uniqueness of our people and finds strength in our differences.
Transparency We strive to provide full visibility to internal and external stakeholders for a complete picture of what we are doing and why.
Honesty and Integrity Trust and mutual respect are essential aspects of our culture. We act with honesty and integrity in all facets of our business, and this serves as the foundation of our work and interactions with others.
Stewardship We are respectful of the resources entrusted to us by the investment community. We act thoughtfully and allocate resources responsibly in seeking to create value for our shareholders.
How

we work together and the behaviors that we show up with each dayarecritical to maintaining our positive culture. Our behavioral expectations align with our values to elevate and drive individual and team performance:
Lead from where you are

regardless of role or level, we motivate each other to achieve common goals.
Drive business results

we navigate forward with our eye on the highest priorities.
Partner and collaborate

we cultivate relationships and value ideas, regardless of where they are coming from, to achieve more together.
Continuously evolve and improve

we try, we learn, we revise and try again.
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
Summer and winter shutdowns
Monthly cell phone stipend
Internal rewards and recognition program
Munch and learns
Medical, Dental, and Vision Insurance
Life andSupplemental life insurance for family
ESPP offering
Health savings account
Flexible spending account for either health care and/or dependent care.
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.
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.

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