Executive Director, Global Compliance Operations Officer

Other Malvern, Pennsylvania


Description

Job Summary - a concise overview of the job

 

Responsible for oversight of the Compliance Operations organization, which includes monitoring, training, policies and communications, and aggregate spend.  Provides leadership for key Compliance initiatives to ensure alignment with business goals and objectives, and adherence to applicable state and federal laws, regulations and industry codes.  Identifies Compliance risk areas and develops strategies, plans and program enhancements to address areas of risk.  A Compliance subject matter expert on application of external regulations and requirements to key activities and processes, policies, and procedures.  Supports the Chief Compliance Officer in carrying out roles and responsibilities; participates on key Compliance and business leadership teams and committees; and is a senior member of the Corporate Compliance Leadership Team.  Responsible for the successful management of the Company’s Corporate Integrity Agreement (CIA) and key driver in development of post-CIA strategic plan. 

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Enterprise-wide

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Oversight of Compliance Operations

Responsible for the oversight of Compliance Operations activities, the successful management of the Company’s activities to ensure alignment with business goals and objectives and adherence to applicable laws, regulations, and industry codes.  Identifies Compliance risk areas and develops strategies, plans, and program enhancements to address areas of risk.  Key driver in development of Compliance post-CIA five-year strategic plan and responsible for the effective execution of such strategic plan.

30%

Leadership and Collaboration

Provides leadership for key Compliance initiatives and collaborates with Senior/Executive management to achieve business and Compliance objectives.  Participates on key Compliance and business leadership teams and committees and is a senior member of the Corporate Compliance Leadership Team.

25%

Planning and Program Development

Provides leadership and oversight for the development and execution of annual Compliance auditing and monitoring plans for the U.S. Pharmaceutical business, policy development, and program enhancements to address Compliance risk areas.  Responsible for expanding the monitoring footprint to include aesthetics, generics, and international business units, to the extent applicable.     

25%

Reporting and Analytics

Responsible for communicating on external compliance-related activities (e.g., enforcements, CIAs, new regulations).  Develops meaningful Key Compliance Indicators (KCIs) to enable Senior/Executive Management to make better informed business decisions.  Transforms existing reporting of monitoring, training and other relevant data points to be more meaningful and insight-driven. Responsible for reporting on key metrics at U.S. Compliance Committee, Global Compliance Committee, and other senior management meetings.

20%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  Bachelor’s Degree required; advanced degree or other relevant certifications preferred.

§  Minimum 15 years of compliance, finance, accounting, legal or other business function experience required; life sciences industry preferred.


Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Knowledge of state and federal laws and regulations, industry guidelines and other requirements  relevant to the Company’s Compliance Program, including government price reporting laws, fraud and abuse and anti-kickback laws, PDMA, OIG and PhRMA guidelines, state and federal aggregate spend reporting requirements, and corporate integrity agreements.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  Strong interpersonal skills including ability to communicate effectively with people individually and groups; ability to communicate with technical and non-technical colleagues

§  Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitating the implementation and acceptance of change within the workplace

§  Able to prioritize and align the organization against goals and objectives; ensures rigor in operational excellence; and focuses on outcomes with clear measures and metrics.

§  Ability to build and manage relationships with business partners and Compliance colleagues

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  Business travel up to 15% of time.

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to chan