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Business Compliance & Integrity Manager

Business Compliance & Integrity Manager

West Pharmaceutical ServicesExton, PA, US
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Business Compliance & Integrity Manager

This role is a hybrid (3 days onsite) in Exton, PA. Candidates applying must reside within a 50 mile commutable distance to the job location.

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

The responsibilities of the Business Compliance & Integrity Manager include protecting the company's assets, enforcing compliance with internal regulations, recommending improvements to our internal control structure, and ensuring compliance with local laws, industry codes and regulations. This position will also act as system administrator for the Business Compliance and Integrity department's monitoring and risk dashboard / platform. The Business Compliance Manager reports to the Chief Compliance & Privacy Officer.

A successful Business Compliance & Integrity Manager should have excellent attention to detail, analytical, and multitasking skills and be completely objective and possess an in-depth working knowledge of the operations and practices within our industry. The Business Compliance & Integrity Manager will assist in the overall compliance and auditing activities to ensure compliance with standard operating procedures, corporate policies, industry standards, and applicable laws for West.

Essential Duties and Responsibilities

  • Supports the planning and executes compliance and privacy auditing and monitoring activities.
  • Supports the daily Data Loss Prevention reviews and communications.
  • Manages the day-to-day operations of the annual compliance auditing and monitoring plan.
  • Initiates and coordinates corrective and preventive action for areas of noncompliance as identified in the periodic audits and / or through the reporting system.
  • Supports the implementation of annual compliance risk assessments.
  • Conducts monitoring of AI activities / plans, including but not limited to, support for timely and fulsome assessments of AI pilot / use case requests and supports the AI Steering Committee.
  • Manages the annual Due Diligence review for agents and distributors.
  • Supports the Business Compliance & Integrity Department with generating reports used to track and trend activities related to compliance.
  • Periodically reviews and recommends updates to compliance policies, procedures and annual compliance auditing and monitoring plan to ensure relevance in providing guidance to management and employees.
  • Identifies potential areas of compliance vulnerability and risk, facilitating corrective action plans for resolution.
  • Remains abreast of relevant regulatory publications and settlements.
  • Collaborates with Chief Compliance & Privacy Officer to develop effective compliance training programs to include new employee orientation, targeted education and ongoing education for management and employees.

Additional Responsibilities

  • Monitors the compliance mailbox, answers questions, and troubleshoots problems for users by phone and email.
  • Provides reports as directed and / or requested to the Chief Compliance & Privacy Officer on issues and concerns.
  • Collaborates with Chief Compliance & Privacy Officer to develop periodic reports for senior management and the board.
  • Assists with the promotion of a compliance culture for the organization.
  • Undertake special projects and duties as identified or assigned.
  • Education

    Bachelor's Degree required

    Work Experience

  • 8-10 years of work experience with 4-7 years of healthcare industry related experience in compliance, operations, privacy, quality, training or applicable experience in pharmaceuticals or medical devices.
  • Project Management certification preferred (or experience in lieu of)
  • Familiarity with compliance, healthcare and privacy laws and regulations, including but not limited to : FCPA, Anti-Kickback, GDPR, PIPL, EU AI Act and other AI regulations
  • Knowledge, Skills and Abilities

  • Exceptional attention to detail, analytical, and statistical skills.
  • Strong written and verbal communication skills.
  • Strong organizational and project management skills.
  • Strong technology skills including Excel and PowerPoint; and experience creating data analytics preferred.
  • Ability to work with and maintain confidentiality of company and personnel data.
  • Must be a self-motivated team player with proven ability to identify issues and manage priorities in a fast-paced environment with a bias for action and a strong sense of ownership.
  • Must be able to meet deadlines and manage multiple priorities.
  • Responsible for identifying system, data, or process improvements that increase efficiency, compliance, or reduce cost to the business.
  • Makes recommendations to compliance leadership, develops and supports execution of plans to implement recommendations in conjunction with compliance management.
  • Demonstrates an aptitude for critical thinking in complex situations and an ability to synthesize ambiguous data into concrete insights and other duties as assigned.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
  • Able to comply with the company's safety and quality policy at all times.
  • Preferred experience as a compliance professional responsible for the development and implementation of risk assessments and monitoring and / or audit programs with working knowledge of DOJ's & OIG's guidance of an effective compliance program.
  • Previous Anti-Kickback Statue compliance risk experience preferred.
  • Previous people management experience preferred.
  • Review and interpret healthcare compliance regulations, policies, procedures and corrective action plans.
  • Ability to be flexible, manage a diverse and demanding workload with minimal supervision.
  • Ability to work effectively within a team environment.
  • Clear, concise and persuasive writing and presentation skills.
  • Decisive and capable of exercising good judgment under pressure.
  • Demonstrated ability to problem solve and manage unforeseen changes to plans.
  • Excellent interpersonal skills and ability to work as a team player.
  • Additional Requirements

  • Weekly staggered work schedule to support APAC and Europe
  • Travel Requirements

    10% : Up to 26 business days per year

    West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and / or a pre-employment drug screening.

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    Compliance Manager • Exton, PA, US

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