The Healthcare Compliance Office (HCO) offers coordination and oversight for all healthcare compliance matters at Genentech and is responsible for the following key areas: Privacy, Compliance Policy Development, Compliance and Ethics Training & Communications; Auditing, Monitoring, and Investigations. As part of its mission to better serve the organization, all members of the HCO team are expected to develop both their depth and breadth of their expertise in one or more of these areas.
The Healthcare Compliance Office (HCO) Compliance Manager Auditing position leads compliance audits across Genentech.
This individual is responsible for conducting complex, in-depth healthcare compliance audits and facilitating corrective action plans within areas of the Genentech organization. This individual designs and effectively executes HCO audits by working closely with other members of the HCO Auditing team or by leading a team comprised of consultants and legal counsel.
Develops and maintains an in-depth understanding of Genentech’s business, organizational structure, reporting relationships, core business practices, policies & procedures, as these relate to healthcare compliance and ethics;
Effectively integrates compliance risk/context, business knowledge, and understanding of database reporting capabilities to develop audit strategies and audit plans;
Executes routine and ad hoc healthcare compliance audits of functional processes across Genentech to ensure adherence to healthcare compliance and ethics policies, guidelines, and SOPs;
Collects, examines, and analyzes records, policies, operating practices, documentation, and transactions;
Performs interviews and walkthroughs with cross-functional stakeholders;
Summarizes and communicates audit progress and findings to various levels of management, both live and in written materials;
Collaborates with other HCO team members, Legal and cross-functional stakeholders in Commercial, Product Development, Medical Affairs, etc. on audit findings;
Draft audit findings and presents audit reports to various levels of management;
Designs, delivers, and oversees effective corrective action plans and/or risk mitigation in partnership with cross-functional stakeholders; tracks to ensure that corrective action plans are completed on a timely basis;
Develops relationships with Genentech personnel across functions and teams and provides coaching and compliance guidance as needed.
As applicable, manages outside consultants and legal counsel to ensure on-time, on-target and within-budget deliverables.
As assigned, assists with other HCO duties and/or projects related to areas such as operations, privacy, investigations, policy, and transparency.
Requires limited direction to complete standard work.
Excellent project management skills: can prioritize multiple tasks and goals to ensure timely, on target and within-budget accomplishment of such.
Proven track record of effective decision-making: makes good business decisions and consistently exercises sound judgment. Applies sound judgment around escalation of issues.
Strong verbal and written business communication skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications.
Strong process-orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness.
Thinks “outside of the box” for solutions. Applies creative problem solving and appropriate business solutions to effectively address compliance risk.
Strong influencing skills: proven track record and experience building and cultivating relationships with key partners and stakeholders across organizational levels. Ability to manage conflict and negotiate corrective actions with cross-functional stakeholders.
Bachelors Degree (finance/accounting, life sciences, law, public policy, marketing, business, or related discipline preferred).
Professional certification preferred (CPA, CIA, CFE, etc.).
Graduate-level Degree preferred (JD, MBA, or related discipline).
Healthcare Compliance Certification (before or w/in 6 months of appointment)
Ability to travel (<less than 10%)
3 or more years of work experience in auditing, compliance, consulting, legal, or investigations (Big 4 accounting firm, consulting firm, or bio/pharma industry related experience preferred).
Previous experience in effectively leading program or project management from inception to implementation.
Knowledge of the bio/pharma industry preferred (compliance, legal, clinical affairs, and product marketing).
Knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry preferred (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
Experience in other compliance disciplines (privacy, policy, healthcare monitoring, transparency) a plus.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.