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Associate Director GVP Research QA

Company: Akebia Therapeutics, Inc.
Location: Cambridge
Posted on: September 15, 2020

Job Description:

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com

Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law. Associate Director GVP Research QA

Quality Assurance

Cambridge, MA

*

ID: 9A-75C

*

Full-Time/Regular

The Associate Director requires strong leadership skills and strategic thinking. Utilizing expert Good Pharmacovigilance Practice (GVP) and knowledge, this role will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization. Other key areas of accountability for this role are to provide professional expertise and strong strategic and technical leadership in Good Pharmacovigilance Practice (GVP) and applicable regulations and guidance and to proactively identify compliance issues/risks.

The ideal candidate will be a part of an expert team supporting global clinical development and post-marketing programs. This includes a special emphasis on pediatric trials.

Required Skills

* Manage the Akebia pharmacovigilance audit and compliance program, including internal process, affiliate, distributor and external vendor audits

* Manage and/or lead diverse & specialized types of audits or projects involving multiple sites, commercial products and/or therapeutic areas.

* Liaises with DSPV management and other internal stakeholders to execute PV compliance activities on multiple commercial product Patient Assistance, Patient Support and Market Research programs, commercial product distributors, business partners and affiliates

* Represent Regulatory Compliance in PV-related Working Groups as appropriate

* Effective compliance reporting to senior management and relevant quality governance forums.

* Investigate critical compliance issues

* Support CAPA development and perform effectiveness checks of CAPAs

* Deliver end-to-end regulatory PV inspection strategy and management, which includes facilitation of regulatory agency PV inspections and partner audits, occurring both in-house and at affiliates.

* Support regulatory agency inspections as needed

* Fosters a commitment to quality in individuals and a culture of quality within the organization.

* Provides expert, timely and risk-based guidance in line with regulations & business needs

* Qualify, and establish agreements with contract auditors

* Direct contract auditors and others who oversee activities performed by contract auditors.

* Evaluate departmental and business area SOPs for fitness for purpose and for compliance with regulatory requirements

* Provide Q&C input on new SOPs, often regarding complex processes entailing complicated cross-functional work and inter business partner relationships.

* Ensure adherence to departmental SOPs across sites.

* Lead intra or interdepartmental teams of an operational nature such as preparing the Company for minor changes in regulations, continuous improvement initiatives.

* Provide leadership, direction, and mentorship to direct reports.

Required Experience

Basic Qualifications:

* BA or BS Degree

* Supervisor experience

* 8+ years of experience in the pharmaceutical industry

* GVP & GCP audit and compliance experience

Preferred Qualifications:

* MS degree

* Recognized as an expert resource on a range of clinical compliance topics.

* Strong verbal and written communication skills and interpersonal skills.

* Proficient in Microsoft Office suite.

* Experience with audit management/CAPA management programs.

* Excellent organization skills and project management.

* Able to work equally well as part of a team or independently

* Ability to travel approximately 25% required.

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com

Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law. * BA or BS Degree

* Supervisor experience

* 8+ years of experience in the pharmaceutical industry

* GVP & GCP audit and compliance experience, * MS degree

* Recognized as an expert resource on a range of clinical compliance topics.

* Strong verbal and written communication skills and interpersonal skills.

* Proficient in Microsoft Office suite.

* Experience with audit management/CAPA management programs.

* Excellent organization skills and project management.

* Able to work equally well as part of a team or independently

* Ability to travel approximately 25% required.

Keywords: Akebia Therapeutics, Inc., Cambridge , Associate Director GVP Research QA, Other , Cambridge, Massachusetts

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