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
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
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
Represent Regulatory Compliance in PV-related Working Groups as
Effective compliance reporting to senior management and relevant
quality governance forums.
Investigate critical compliance issues
Support CAPA development and perform effectiveness checks of
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
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
Required Experience Basic Qualifications:
BA or BS Degree
8+ years of experience in the pharmaceutical industry
GVP & GCP audit and compliance experience
Recognized as an expert resource on a range of clinical
Strong verbal and written communication skills and interpersonal
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.