The Director of Compliance will be responsible for the design, implementation, oversight, and enforcement of policies and practices to ensure corporate compliance with global regulatory requirements relevant to public pharmaceutical companies. The successful candidate will interface with all departments across Glenmark to promote and oversee the corporate strategy and assessment of regulatory compliance. The Director of Compliance will report to the Legal Head North America with a matrix reporting to the President North America.
Developing, managing, and monitoring compliance strategy, philosophy, and processes;
Developing corporate compliance policies and processes to ensure company conduct is in accordance with global regulatory requirements, industry guidance, and best practice;
Establishing standards and implementing procedures to ensure that the compliance programs throughout the organization are effective and efficient in identifying, preventing, detecting, and correcting noncompliance with applicable rules and regulations;
Developing policies and programs that encourage managers and employees to report suspected fraud and other improprieties without fear of retaliation;
Establish and maintain global whistleblower hotline for the anonymous reporting and follow-up of misconduct and potential compliance or ethical breaches from employees, contractors, and customers; conduct and document associated investigations;
Developing training programs and learning platforms for all applicable disciplines and functional areas including but not limited to the company's business ethics and compliance policies and procedures. Periodically assess these programs for effectiveness;
Conduct Training programs
Develop and maintain strong and productive working relationships with key stakeholders both internally and externally to maintain compliance awareness and effective compliance assurance processes;
Lead initiatives to identify and address challenges and/or compliance issues in the cross-functional environment through compliance related investigations and fact-finding activities;
Maintain current awareness of laws, regulations, emerging trends and proposed regulations/guidelines and industry best practices in the regulatory compliance arena;
Conduct internal investigations as deemed necessary
Respond to government investigations and inquiries as the principal point of contact.
Education/Experience:
J.D. preferred, but would consider an advanced degree in the pharmaceutical sciences, quality assurance, or compliance;
10-12 years of experience in corporate compliance and management/leadership in a multi-national pharmaceutical environment or relevant government entity;
Knowledge/Skills:
Demonstrated ability leading cross-cultural, cross functional, high-performance teams;
Demonstrated strong track record of partnering with business management to provide guidance and implementation of effective compliance processes;
Ability to lead Glenmark’s compliance program strategically as the company grows but also roll-up one’s sleeves to get the work done;
Exceptional critical thinking and problem solving skills;
Ability to work in a fast-paced, high volume environment and meet challenging deadlines;
Strong listening and organizational skills;
Self-motivated and goal oriented
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