Compliance Officer jobs in United States, Pennsylvania, Newtown Township

• 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.
  

• 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.

Bachelor's Degree required

• 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

• 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.

• Weekly staggered work schedule to support APAC and Europe

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Support drug substance manufacturing process development activities by executing downstream purification steps at bench-scale and pilot-scale
• Support the development of new purification technologies to improve the efficiency of the Biologics manufacturing process and reduce the cost of goods
• Execute development studies (for example, virus clearance study) at 3rd party labs
• Lead a compliant laboratory operation in accordance with SOPs, internal procedures and policies
• Assist in troubleshooting process and equipment issues and deviations
• Record experiment results in lab notebooks in compliance with Good Documentation Practice, and perform data analysis as needed
• Analyze data and present it at internal team meetings and effectively communicate with supervisor(s)/project leads
• Prepare/review technical documents including development reports, batch records, work instructions, etc
• Interact cross-functionally with upstream process development, analytical, facilities, and other internal and external functions to support successful process development and manufacturing in pilot-scale lab

Additional Responsibilities / Secondary Duties:

• Support cGMP (Current Good Manufacturing Practices) clinical manufacturing campaigns in Biologics Manufacturing Facility, when needed

Qualifications / Education Requirements:

• BS in Chemical engineering or Biotechnology or Chemistry or Biology or related field
• Excellent verbal and written communication skills required.
• Highly motivated individual with the ability to work collaboratively in a team environment.
• Knowledge of protein chemistry and separation science is preferred
• Some previous laboratory coursework or experience is preferred.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

This position will be responsible to coordinate, execute and maintain trade related programs for West EU locations. The focus will be on executing and maintaining compliance for West products, procurement and sales activities for EU cross-border transactions. The role is responsible to ensure West transactions are compliant with EU national, regional and local import and export laws and requirements and to ensure efficient and consistent cross border transactions.

• Responsible for ensuring West EU import and export declarations adhere to applicable SOP’s to minimize compliance exposure and to optimize costs
• Executes cross border activities according to the EU trade compliance manuals and procedures
• Works with West sites, 3rd party service providers, and customs broker(s) to resolve issues and questions that arise regarding day-to-day customs entries and export declarations
• Provides trade compliance related codes such as HS, export control codes, Partner Government Agency codes, and other compliance related master data for EU imported and exported products
• Maintain and, as necessary, retrieves required records relating to import and export affairs.
• Prepares, submits and maintains special compliance related documentation to support import/export declarations
• Provides transactional support for duty optimization programs such as Free Trade Agreements
• Conducts post-entry audits---Coordinate any Post Entry Corrections, where necessary, with West-designated Customs Broker.
• Reviews and manages documentation required for import/export declarations, use of Free Trade Agreements, Preferential Duty Programs and Duty Drawback Programs
• Participates in and supports operational projects involving or impacting Trade Compliance at West EU facilities (e.g. systems implementations, new business models, etc.)
• Participates in cost-saving and process improvement initiatives for Trade Compliance activities
• Other duties as assigned

• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Must be able to maintain confidentiality and resolve conflicts
• Ability to make independent and sound judgments
• Read and interpret data, information, and documents
• Analyze and solve problems

• High School Diploma required
• Bachelor's Degree Business or relevant field preferred

• Minimum 3 years related experience required.

• Working knowledge of EU import/export regulations and TARIC
• AEO certification/program knowledge
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy always
• Able to comply with the company’s quality policy always.
• Strong analytical ability
• Solid communication skills
• Ability to speak English
• Ability to work with and within global cross-functional teams

This hybrid position is responsible for coordinating, executing, and maintaining trade-related programs for West's North America (NA) locations. The primary focus is on ensuring compliance in executing and maintaining West's procurement, sales activities, and cross-border transactions. The role ensures that all West transactions comply with U.S. national, regional, and local import and export laws and requirements to facilitate efficient and consistent cross-border transactions.

• Ensure that West NA import and export declarations comply with applicable Standard Operating Procedures (SOPs) to minimize compliance risks and optimize costs.
• Execute cross-border activities according to the NA trade compliance manuals and procedures.
• Collaborate with West sites, third-party service providers, and customs brokers to resolve issues and questions regarding daily customs entries and export declarations.
• Provide trade compliance-related codes such as Harmonized Tariff Schedule (HTS) codes, export control codes, Partner Government Agency codes, and other compliance-related master data for NA imported and exported products.
• Maintain and retrieve, when necessary, records related to import and export affairs.
• Prepare, submit, and maintain special compliance-related documentation to support import/export declarations.
• Deliver transactional support for duty optimization programs, including Free Trade Agreements.
• Conduct post-entry audits and coordinate any necessary Post Entry Corrections with West-designated Customs Brokers.
• Review and manage documentation required for import/export declarations and the use of Free Trade Agreements, Preferential Duty Programs, and Duty Drawback Programs.
• Participate in and support operational projects impacting Trade Compliance at West NA facilities (e.g., system implementations, new business models).
• Engage in cost-saving and process improvement initiatives for Trade Compliance activities.
• Perform other duties as assigned.

• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Must be able to maintain confidentiality and resolve conflicts
• Ability to make independent and sound judgments
• Read and interpret data, information, and documents
• Analyze and solve problems

• Degree in Business, International Trade, Logistics or other relevant field, or equivalent related experience

• 3 years minimum of related experience required.

• Working knowledge of the U.S. Harmonized Tariff Schedule (US HTS), Export Commodity Control Numbers, Schedule B Numbers, and Title 19 Code of Federal Regulations - Customs Duties.
• Customs Trade Partnership Against Terrorism (CTPAT) certification/program knowledge.
• Ability to follow all relevant SOPs as per Company policy related to the position.
• Support and contribute to Lean Sigma programs and activities towards achieving set targets.
• Continuous compliance with the company’s safety and quality policies.
• Strong analytical skills.
• Excellent communication skills.
• Ability to work collaboratively within global cross-functional teams.
• Capability to work within a remote or matrix organization

• Occasional stretching and arm extension for work related tasks/assignments
• Occasional bending and twisting as required by the job

This position is responsible for coordinating, executing, and maintaining trade-related programs for West's North America (NA) locations. The primary focus is on ensuring compliance in executing and maintaining West's procurement, sales activities, and cross-border transactions. The role ensures that all West transactions comply with U.S. national, regional, and local import and export laws and requirements to facilitate efficient and consistent cross-border transactions.

• Ensure that West NA import and export declarations comply with applicable Standard Operating Procedures (SOPs) to minimize compliance risks and optimize costs.
• Execute cross-border activities according to the NA trade compliance manuals and procedures.
• Collaborate with West sites, third-party service providers, and customs brokers to resolve issues and questions regarding daily customs entries and export declarations.
• Provide trade compliance-related codes such as Harmonized Tariff Schedule (HTS) codes, export control codes, Partner Government Agency codes, and other compliance-related master data for NA imported and exported products.
• Maintain and retrieve, when necessary, records related to import and export affairs.
• Prepare, submit, and maintain special compliance-related documentation to support import/export declarations.
• Deliver transactional support for duty optimization programs, including Free Trade Agreements.
• Conduct post-entry audits and coordinate any necessary Post Entry Corrections with West-designated Customs Brokers.
• Review and manage documentation required for import/export declarations and the use of Free Trade Agreements, Preferential Duty Programs, and Duty Drawback Programs.
• Participate in and support operational projects impacting Trade Compliance at West NA facilities (e.g., system implementations, new business models).
• Engage in cost-saving and process improvement initiatives for Trade Compliance activities.
• Perform other duties as assigned.

• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Must be able to maintain confidentiality and resolve conflicts
• Ability to make independent and sound judgments
• Read and interpret data, information, and documents
• Analyze and solve problems

• College Degree in Business, International Trade, Logistics or other relevant field, or equivalent related experience

• 3-5 years of related experience.

• Working knowledge of the U.S. Harmonized Tariff Schedule (US HTS), Export Commodity Control Numbers, Schedule B Numbers, and Title 19 Code of Federal Regulations - Customs Duties.
• Customs Trade Partnership Against Terrorism (CTPAT) certification/program knowledge.
• Ability to follow all relevant SOPs as per Company policy related to the position.
• Support and contribute to Lean Sigma programs and activities towards achieving set targets.
• Continuous compliance with the company’s safety and quality policies.
• Strong analytical skills.
• Excellent communication skills.
• Ability to work collaboratively within global cross-functional teams.
• Capability to work within a remote or matrix organization

• Occasional stretching and arm extension for work related tasks/assignments
• Occasional bending and twisting as required by the job