Senior Specialist, Quality Systems and Compliance

Job Description

About the Role

Location: Waltham United States

Job Description:

Company Description

Job Description

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.

This position will report to the Associate Director, Quality Systems and Compliance and can be performed remotely within the US.

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.

Qualifications

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.

Additional Information

Deciphera offers a comprehensive benefits package that includes but is not limited to 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

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

Deciphera, a member of ONO, is a 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.