Overview
Senior Specialist, Quality Systems and Compliance Jobs in Waltham, Massachusetts, USA at Deciphera Pharmaceuticals
Senior Specialist, Quality Systems and Compliance
The Role:
We are seeking a Senior Specialist, Quality Systems and Compliance to provide quality expertise to support our QS&C team for the development and commercialization of Deciphera’s products in compliance with relevant US, EU and ICH requirements. The primary responsibilities of this role will be supporting the Quality Systems and Compliance department to ensure GxP compliance. We are looking for a teammate that can partner with internal departments to support the Document Control (eDMS), Learning Management System (LMS), and Quality Management Systems (QMS), and to implement process improvements to meet business and regulatory requirements.
What You’ll Do:
Supports the day-to-day management of the Quality Systems and Compliance department, including the Document Control function.
Assist with the development and implementation of Quality Systems SOPs, Work Instructions, training materials and reference guides.
Assists in delivery, maintenance, and continuous improvement of cross-GxP processes in eDMS, LMS, and QMS.
Generate compliance metrics and prepare routine KPI reports.
Participate in system validation activities as required.
Assist in the identification and implementation of continuous improvement opportunities.
Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
Participate in regulatory inspections for our global clinical and commercial programs as needed.
What You’ll Bring:
4+ years in Quality Systems/Quality Assurance experience in the life sciences industry.
Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience strongly desired.
Strong software proficiency with Microsoft Suite and other desktop applications, experience using Veeva Vault would be desired.
Experience developing improvements to electronic Quality Systems.
Bachelor’s degree in Computer Science, Life Science or related field or applicable experience.
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 communication and collaboration skills.
Must be authorized to work in the US.
Benefits:
Competitive salary and annual bonus.
Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
Generous parental leave and family planning benefits.
Outstanding culture and opportunities for personal and professional growth.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Science
Pharmaceutical Manufacturing
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Title: Senior Specialist, Quality Systems and Compliance
Company: Deciphera Pharmaceuticals
Location: Waltham, Massachusetts, USA
Category: Quality Assurance – QA/QC, IT/Tech
