Title:  Senior Counsel, Compliance, Regulatory & Quality

Job Summary

The Sr. Counsel, Compliance Regulatory and Quality role is a strategic, business-oriented partner to provide integrated legal leadership across the Company’s global Compliance, Regulatory Affairs and Quality Assurance functions.

Reporting to and working in close partnership with our General Counsel and Chief Compliance Officer, this role is a key legal advisor to the Company in the area of overall Compliance, including privacy, and helps to oversee and manage West’s global compliance program. As a key legal advisor to our Regulatory Affairs and Quality Assurance functions, this position plays an important role of helping ensure that our quality governance frameworks align with global regulatory requirements and enforcement trends. #LI-CT1

Essential Duties and Responsibilities

• Help lead global compliance strategy and implementation aligned with enterprise risk management and business objectives, under the oversight of the General Counsel and Chief Compliance Officer.
• Manage and develop the compliance team, currently including one compliance attorney, one compliance manager and one privacy senior manager.
• Execute appropriate compliance audit and monitoring mechanisms to assess the effectiveness of internal controls addressing regulatory, ethical, operational risks and financial controls in accordance with SOX (in collaboration with our Internal Audit and Finance functions).
• Monitor and interpret developments on relevant laws, regulations, and industry best practices, and ensure the company's compliance with them.
• Identify potential compliance risks both internally and externally, including those associated with third-party vendors and business partners, and develop mitigation strategies to minimize the organization's exposure to legal and regulatory issues.
• Create and/or revise compliance policies and procedures to address regulatory requirements and industry standards.
• Design and deliver global compliance training and awareness programs to promote compliance with the organization's policies.
• Help oversee internal investigations across global operations into potential compliance violations and assist as needed with employment-related investigations in partnership with Human Resources and Legal  departments .
• Prepare regular compliance reports for senior management and board members, summarizing compliance risks, investigations, program effectiveness and emerging compliance developments.
• Promote a culture of integrity, accountability and ethical decision-making throughout the organization.
• Serve as a key legal advisor to the Quality Assurance and Regulatory Affairs functions.
• Provide legal guidance and support on Quality Management Systems (QMS), CAPA and investigation processes, audit findings (internal, customer, regulatory), supplier quality issues, product quality events and remediation strategies.
• Advise on global regulatory frameworks applicable to pharmaceutical packaging, containment, and delivery systems.
• Provide legal guidance related to: FDA and international health authority requirements; registration, submission, and regulatory approval matters; regulatory inspections and enforcement actions; and supplier and customer regulatory obligations.
• Manage outside counsel relationships when necessary for compliance and regulatory matters, including scope and budget oversight.

Education

• JD Law Degree or equivalent experience

Work Experience

• 12+ years of legal experience, including compliance, regulatory and investigation experience in the life sciences space

Preferred Knowledge, Skills and Abilities

• Experience administering or leading a corporate compliance program in a highly regulated industry, including people-management experience and skills.
• Preferred experience working in pharmaceutical, medical device, biotech or manufacturing industries.
• Strong understanding of relevant regulations and industry standards applicable to the organization, including frameworks impacting pharmaceutical and medical product supply chains.
• Excellent oral and written communication skills.
• Analytical and problem-solving abilities.
• Familiarity with compliance software and tools.
• Ability to adapt to changing regulatory environments and ensure the organization's ongoing compliance.
• Strong interpersonal skills to work collaboratively with cross-functional teams and multiple stakeholders across multiple geographies.
• Ability to maintain confidentiality at all times.
• Dependability, attention to detail with strong organizational and time management skills a must.
• Strong leadership skills, with the ability to influence and collaborate with senior leadership and legal counsel.
• Able to comply with the Company’s safety and quality policies at all times.

Travel Requirements

Physical Requirements

Additional Requirements

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• This role is sedentary and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• Read and interpret data, information and documents
• 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
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

What We Offer