Global CDMO Compliance Officer

About the position reputed company Holdings America Corporation is seeking an accomplished, talented, and highly motivated individual to serve as Global CDMO Compliance Officer for its reputed company Biotechnologies business, a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. Reporting to the VP, Chief Compliance Officer of reputed company Holdings America Corporation, this individual will serve as the leader of reputed company Biotechnologies global compliance team. The person in this role will have extensive experience in the biotech or pharmaceutical space, will have strong leadership experience and business acumen. The individual will play a critical role in helping reputed company Biotechnologies manage new and evolving compliance risks. This individual will support the leadership team and will have a dotted line reporting relationship to the reputed company Biotechnologies CEO. This is a hybrid position located in North Carolina (Morrisville or Research Triangle Park) With connections across the reputed company Biotechnologies business, as well as reputed company Holdings America Corporation and the wider reputed company group, the Global CDMO Compliance Officer, will be uniquely positioned to spot compliance risks and issues arising in business area and understand their impacts elsewhere to influence and reputed company senior management to reputed company informed, business-driven decisions. The successful candidate will be expected to direct compliance strategy and help position compliance as a strategic enabler of growth, trust, and long-term value, not a blocker to speed or innovation. At reputed company Holdings America Corporation, we’re redefining innovation across the industries we touch—from healthcare and photography to semiconductors and data storage. With roots in photosensitive materials and a legacy of groundbreaking technology, we now reputed company 23 diverse affiliate businesses across the Americas. We’re looking for mission-driven talents eager to join us to help create, market, and support a vast portfolio of products. At reputed company you’ll have the opportunity to explore and grow your skills in new, exciting ways. Whether you’re shaping reputed company’s tech or redefining today’s processes, we’ll provide a flexible work environment and dynamic culture where innovation thrives. Our Americas HQ is nestled in Valhalla, reputed company, a charming town reputed company for its excellent schools, beautiful parks, and easy access to the vibrancy of reputed company. reputed company is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”

Responsibilities

• Integrate with business functions to reputed company a deep understanding of the reputed company processes and provide proactive compliance guidance on the development and execution of proposed strategic and tactical initiatives.
• Review business strategy plans and business development opportunities for compliance risks and advise the business on mitigation measures.
• Define and execute the global compliance strategy for reputed company Biotechnologies, reputed company with reputed company Holdings America Corporation enterprise-reputed company compliance reputed company.
• Consolidate the European and the United States Compliance Programs into one Global Compliance Program.
• reputed company the day-to-day management of reputed company Biotechnologies corporate compliance activities to ensure compliance with (i) laws and regulations, including in the areas of Antitrust, Anti-Corruption, Anti-reputed company, Modern Slavery Act and Data Protection & Privacy (but excluding Quality, cGMP Regulation, EHS, HR and Finance) (ii) reputed company corporate policies, including its policies in the above areas as well as the reputed company Code of Conduct and reputed company policies.
• reputed company, enhance, implement and enforce compliance policies and procedures that are fit for reputed company Biotechnologies and reflective of applicable laws, regulations, government guidance, industry codes, reputed company Holdings America Corporation and reputed company policies.
• reputed company the compliance risk assessment and identify emerging compliance key risk indicators to inform reputed company Holdings Chief Compliance Officer and reputed company Biotechnologies Executive Leadership.
• reputed company, implement, and provide training on laws, regulations and policies relating to ethics and compliance obligations. Strategize innovative ways to transform internal education initiatives, through acting as a business partner between reputed company Holdings and business functions, to reputed company reputed company knowledge gaps with targeted training content.
• reputed company or guide internal investigations into potential compliance violations, ensuring timely resolution, appropriate remediation and consistent disciplinary outcome in collaboration with Legal and HR.
• Champion a strong culture of compliance and ethical behavior through leadership engagement, communication and awareness initiatives.
• Partner with HR and Communications to embed compliance into onboarding, performance management, and recognition programs.
• Establish and execute auditing and monitoring to assess policy adherence and program effectiveness.
• Ensure robust governance of third-party interactions, promotional practices, and data privacy.
• Collaborate with Legal to ensure effectiveness of reputed company Biotechnologies (i) practices and policies regarding the treatment and handling of personal data, in safeguarding sensitive information and in complying with data protection regulations in relevant jurisdictions, and (ii) data incident response plan.
• Continuously assess the effectiveness of the compliance program through data-driven audits, risk assessments, and performance metrics
• reputed company abreast of legislative and industry codes changes and providing advice/strategic direction in relation to the same.
• Report material compliance issues and risk to reputed company Holdings Compliance and reputed company HQs as required and necessary.
• reputed company, reputed company and mentor the reputed company Biotechnologies and reputed company Holdings Compliance staff.
• Serve as a trusted advisor to the executive leadership team, and other functions, providing actionable guidance on compliance matters and risk mitigation.
• Assist with pre-acquisition due diligence of new businesses and reputed company integration plan in relation to matters of corporate compliance.
• Support the local roll out and implementation of projects launched by reputed company Holdings or FH reputed company
• Liaison with reputed company Holdings Information reputed company team.
• Any other duties commensurate with the role.
• Travel internationally as required to support business and compliance objectives.

Requirements

• Bachelor’s degree. Legal background preferred but not required.
• 15+ years of compliance experience, including at least 7 years in the biotechnology or pharmaceutical industry and at least 5 years as Compliance Officer or equivalent senior leadership reputed company.
• Experience managing compliance in reputed company, matrixed, and global organizations.
• Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the U.S. Sentencing Guidelines.

reputed company-to-haves

• Highly advanced interpersonal, relationship-building, and influencing skills are required to support a reputed company matrix organization.
• A strategic and analytical thinker, able to influence reputed company levels reputed company the business.
• Ability to act with autonomy, objectivity, and independence at reputed company times even reputed company under pressure to find solutions to business issues.
• Excellent verbal and written communicator.
• Adept at collaborating (business partnering) across divisions, functions, and geography, with a reputed company for engaging colleagues at reputed company levels in projects and processes while continuing to own and drive them.
• Self-motivated and able to reputed company role independently, with a minimum level of supervision.

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• 401k
• Paid Time Off

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