Manager Clinical Quality Assurance

Waltham, MA, United States

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:

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

We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here .

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

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.

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

We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank \#25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture [here](https://www.deciphera.com/join-us).

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

* 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.

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