Senior Specialist, Quality Systems and Compliance

5 hours ago

🇺🇸 United States – Remote

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

Description

• Support Quality Systems and Compliance department, including Document Control function. • Assist with the development and implementation of Quality Systems SOPs, Work Instructions, training materials and reference guides. • Maintain and continuously improve cross-GxP processes in eDMS, LMS, and QMS. • Generate compliance metrics and prepare routine KPI reports. • Participate in system validation activities as required. • Identify and implement 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 global clinical and commercial programs as needed.

Requirements

• 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

• 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 • Health savings account with company contribution • Flexible spending account for either health care and/or dependent care. • Family planning benefit • Generous parental leave