Compliance Operations Director

Merck & Co.; Bridgewater (MA); On-site; USD 190,000 - 230,000; Full time

Benefits offered by this job

Competitive benefits

401(k) matching

Job summary

Amneal is seeking a senior Compliance leader to oversee a broad portfolio including policy governance, training, and third-party due diligence. You will coordinate with global functions to maintain and improve the compliance program and ensure policies align with evolving regulations.

The role requires strong collaboration across departments, deep regulatory knowledge, and a track record of building effective governance structures within the pharmaceutical industry.

Qualifications

• Bachelor's degree (BA/BS) required.
• Minimum 5 years in the pharmaceutical industry, specifically in compliance, legal, or audit.
• Strong knowledge of regulatory guidance affecting corporate compliance programs (e.g., OIG, PhRMA, False Claims Act).

Responsibilities

• Develop, maintain and update global compliance policies and SOPs.
• Lead and manage the Third Party Due Diligence (TPDD) program in the U.S.
• Operate and maintain the global compliance training program and related records.
• Coordinate and monitor the compliance monitoring program across business partners.
• Collaborate with HR, Finance, IT and other functions to align policies and governance.

Skills

Policy development

Training program development

Compliance monitoring

Third-party due diligence

Cross-functional collaboration

Education

Bachelor's degree

Job description

Description:

This position serves as a multifaceted leadership role within the Compliance function, overseeing a diverse portfolio of responsibilities. The successful candidate will lead key operational aspects of Amneal's Compliance program, including managing our global third-party due diligence program, maintaining and updating all Amneal Compliance policies and SOPs, managing and developing the Amneal Compliance training program, and managing and coordinating Amneal's Compliance monitoring program. This role requires strong collaboration and relationship building across departments and functions. The position is highly visible throughout the organization and plays a key role supporting core business activities and providing guidance to cross-functional teams.

Essential Functions:

• Develop, Maintain and Update Global Compliance Policies and SOPs.
• Serve as the primary source and advisor to all Amneal colleagues on the content and applicability of Amneal Compliance policies and SOPs.
• Lead and manage the annual policy review and refresh process, identify areas where new policies or SOPs are needed and implement appropriate updates to existing policies and SOPs.
• In collaboration with Corporate Communications, draft and distribute communications relevant to new or revised policies.
• Maintain close collaboration with other control functions (e.g. Human Resources, Finance, IT) regarding the need for, and scope of, Compliance policies and SOPs in relation to those of other functions.
• Operate and Maintain Amneal's Global Compliance Training Program. Develop and launch training across multiple formats to reinforce Amneal Compliance policies, SOPs, and corporate compliance culture.
• Provide relevant training to colleagues across all Amneal functions, as appropriate.
• Equip colleagues within Compliance and other functions to effectively provide Compliance training, as appropriate. Explore cost-effective options to improve the effectiveness of Amneal's Compliance training program.Maintain all Compliance training records in a centralized database and make them available to relevant functions, as needed.
• Lead and Manage Third Party Due Diligence (TPDD) Program in the U.S.
• Serve as the primary point of contact for colleagues globally regarding the operation of Amneal's TPDD system in the U.S.Run preliminary reports on potential third parties and advise and counsel colleagues on potential risks and mitigation. Facilitate the distribution of external due diligence questionnaires, as necessary.Provide trainings to colleagues on the due diligence SOP and on how to use the due diligence review platform.
• Manage and Coordinate Amneal's Compliance Monitoring Program.
• Develop and socialize the annual monitoring plan for U.S. business partners.
• Collaboratively arrange for monitoring opportunities with business functions.
• Coordinate monitoring assignments with other members of the U.S. Compliance team.
• Analyze and communicate monitoring results and remediation plans to business partners.Maintain all records and data related to compliance monitoring work.

Education:

• Bachelors Degree (BA/BS) - Required

Experience:

• 5 years or more in 5 years or more experience required in the pharmaceutical industry, specifically in compliance, legal, or audit

Specialized Knowledge:

• Working knowledge of various laws, regulations and industry guidance that affect Amneal's Corporate Compliance Program (e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, industry guidance documents, CIA trends, regulations regarding the promotion of marketed products, Open Payments and the False Claims Act and Anti-Kickback Statutes).
• Demonstrated understanding and experience developing Compliance program policies and governance structures, which include controls and requirements that incorporate key elements of OIG guidance and the U.S. Department of Justice Criminal Division Evaluation of Corporate Compliance Programs.

The base salary for this position ranges from $190,000 to $230,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.