Healthcare Compliance Office (HCO) Senior Compliance Manager - Auditing

Genentech•Daly City, CA

1d•Onsite

About The Position

The Position The Opportunity The Healthcare Compliance Office (HCO) Sr. Compliance Manager Auditing position leads internal 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. In the role, this individual: Uses knowledge of compliance risks and understanding of database reporting capabilities to develop audit strategies and audit plans Executes routine and ad hoc healthcare compliance audits of department/function 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; prepares and presents audit reports; recommends opportunities to strengthen the internal control structure and assists with corrective action planning 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 across the organization on audit findings, recommended corrective actions and/or risk mitigation Conducts routine and ad hoc follow-up from previous auditing activities to ensure corrective actions or other remedies have been sufficiently completed in a timely manner Develops relationships with Genentech personnel across functions and teams and provides coaching and compliance guidance as needed or otherwise appropriate Escalates issues to HCO investigators or others, according to established departmental procedures and protocols Contributes to the annual and longer-range Work Plan and Audit Plan development and implementation Where applicable, manages outside consultants and legal counsel to ensure on-time, on-target and within-budget deliverables Proactively identifies trends, dynamics or other factors influencing Genentech’s overall healthcare and related compliance to provide forward input into future HCO plans and objectives Assists with other HCO duties and/or projects related to areas such as operations, monitoring, investigations, policy, training, and transparency Who You Are Has impeccable ethics 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 Strong business acumen: understands how the business “works” and demonstrates consistently effective “navigation” across the organization. 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. Demonstrates ability to identify appropriate resources. Exercises good judgment in terms of when to leverage internal resources.

Requirements

Has impeccable ethics
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
Strong business acumen: understands how the business “works” and demonstrates consistently effective “navigation” across the organization.
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.
Demonstrates ability to identify appropriate resources. Exercises good judgment in terms of when to leverage internal resources.
Bachelors Degree required (life sciences, law, public policy, marketing, business, education, finance/accounting or related discipline preferred)
6 or more years of work experience in legal, compliance, auditing, or investigations (bio/pharma industry related experience or consulting firm experience preferred)
Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, and product marketing)
Must demonstrate in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.)
2 or more years of previous experience effectively leading program or project management from inception to implementation

Nice To Haves

Professional certification preferred (CFE, CIA, CPA, etc.)
Graduate-level Degree preferred (JD, MBA, MEd or related discipline)
Healthcare Compliance Certification preferred (before or w/in 6 months of appointment)
Ability to travel

Responsibilities

Uses knowledge of compliance risks and understanding of database reporting capabilities to develop audit strategies and audit plans
Executes routine and ad hoc healthcare compliance audits of department/function 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; prepares and presents audit reports; recommends opportunities to strengthen the internal control structure and assists with corrective action planning
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 across the organization on audit findings, recommended corrective actions and/or risk mitigation
Conducts routine and ad hoc follow-up from previous auditing activities to ensure corrective actions or other remedies have been sufficiently completed in a timely manner
Develops relationships with Genentech personnel across functions and teams and provides coaching and compliance guidance as needed or otherwise appropriate
Escalates issues to HCO investigators or others, according to established departmental procedures and protocols
Contributes to the annual and longer-range Work Plan and Audit Plan development and implementation
Where applicable, manages outside consultants and legal counsel to ensure on-time, on-target and within-budget deliverables
Proactively identifies trends, dynamics or other factors influencing Genentech’s overall healthcare and related compliance to provide forward input into future HCO plans and objectives
Assists with other HCO duties and/or projects related to areas such as operations, monitoring, investigations, policy, training, and transparency