Director, QA Systems and Compliance - Redwood City, CA | Biospace
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Director, QA Systems and Compliance

Relypsa Inc.

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Location:
Redwood City, CA
Posted Date:
1/17/2017
Position Type:
Full time
Job Code:
439
Salary:
DOE
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Company Overview

Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company.  More information is available at www.relypsa.com.

Product Overview

Veltassa® (patiromer) for oral suspension was approved in October 2015 for the treatment of hyperkalemia, a condition defined as elevated blood potassium levels that can cause abnormal heart rhythms and even sudden death. A potassium binder, Veltassa® is the first new medicine for the treatment of hyperkalemia in more than 50 years and is the first commercialized medicine resulting from Relypsa’s polymer technology platform. Relypsa is committed to ensuring that people living with the burden of hyperkalemia have access to Veltassa®.


Position Overview

Relypsa is seeking a talented and experienced compliance professional to help lead the continued development and enhancement of the Relypsa Healthcare Compliance Program.  Reporting into the Relypsa Chief Healthcare Compliance Officer, the preferred candidate will be a self-starter, pragmatic, possess exceptional critical thinking and analytical skills, and have strong knowledge and ability to apply U.S. healthcare fraud and abuse laws and guidance (e.g., Anti-kickback Statute, False Claims Act, Food Drug and Cosmetic Act, HIPAA, Sunshine Act, Prescription Drug Marketing Act, OIG Guidance) to Relypsa’s business strategies and activities.

Moreover, the right individual will thrive in an entrepreneurial environment where they will have the authority and autonomy to help define Healthcare Compliance Program goals and contribute to cross-functional projects that stretch beyond pure healthcare compliance topics (e.g., hub operations).  As the Chief Healthcare Compliance Officer’s deputy, this individual must exhibit uncompromising ethics, excellent communication and influencing skills, and sound judgment to effectively advise internal clients ranging from field sales representatives to executive leadership around all facets of the Relypsa Healthcare Compliance Program.          

Position Responsibilities:

•   Lead the Company’s compliance monitoring and auditing programs with an emphasis on designing novel mechanisms to help assess not only compliance with Company policies and procedures, but also training gaps
•   Support the Chief Healthcare Compliance Officer and Legal department colleagues with the design and execution of a robust healthcare compliance risk assessment process to help inform executive leadership of potential healthcare compliance vulnerabilities
•   Collaborate with key stakeholders in HR, Sales Training, Medical, Market Access, Legal and IT to augment the Company’s healthcare compliance training processes and systems so that employees experience comprehensive, but tailored training content starting with new hire onboarding to annual continuing employee compliance curricula
•   In collaboration with vendor support, manages the implementation and continued oversight of the Relypsa aggregate spend program, including: chairing the project steering committee, coordinating processes for the capture and reproting of data from applicable internal and third party spend systems, and providing final review and approval for Federal and State disclosure reports pursuant to submission deadlines
•   As necessary, conduct or provide oversight of healthcare compliance investigations in collaboration with HR, Legal and/or external legal counsel
•   Support cross-functional teams with the development and/or improvement of company policies and procedures with impact to the Healthcare Compliance Program
•   Advise and maintain relationships with key Relypsa clients, including field sales representatives, Medical Science Directors, Field Logistics Managers, as well as home office colleagues from Sales Training and Operations, Marketing, Medical Affairs and Market Access
•   Advise and maintain relationships with key Vifor stakeholders, including the Vifor General Counsel, Head of Compliance, and legal and compliance leadership from other Vifor affiliates and joint venture partners
•   Continually reassess status of Relypsa Healthcare Compliance Program against healthcare industry enforcement actions, evolving laws, codes and guidance, and provide recommendations to Chief Healthcare Compliance Officer and executive leadership teams on how to continue to advance the Program

Requirements

•   A Bachelor’s degree required; an advanced degree, such as a JD is preferred
•   Strong knowledge and understanding of drug regulation, PhRMA Code, Anti-kickback statute, OIG Guidance, and Federal and State disclosure requirements, specifically, experience implementing Sunshine Act requirements and preparing annual Sunshine act and State law reports
•   A minimum of 5-10 years of experience in a pharmaceutical and/or healthcare organization compliance function, especially in a start-up and global environment
•   Demonstrated ability to implement and manage a Healthcare Compliance Program
•   Familiarity with pharmaceutical sales, marketing, market access hub operations and tactics
•   Proven ability to work in a team setting within a matrixed organization
•   Willingness to travel domestically and internationally (20% of time)

As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Relypsa’s high regard for our employees.



NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.



Relypsa is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.