Sr. Manager Labelling

Job Description

In this critical leadership role, the Senior Manager, Global Labeling Compliance will oversee the planning and execution of global labeling compliance initiatives for our portfolio. You will lead a dedicated team of labeling professionals and work cross-functionally to ensure all labeling activities meet regulatory, quality, and operational standards. As a key liaison between regional and global stakeholders, your leadership will ensure the timely and accurate delivery of labeling across multiple markets. This role is vital to ensuring our organization remains at the forefront of compliance and innovation in the biotech industry.

Key Responsibilities:

1. Leadership & Team Management:

- Manage and develop a team of labeling specialists, providing direction, mentorship, and performance feedback to foster professional growth.
- Create a collaborative environment, guiding cross-functional teams to meet global labeling objectives and deliverables.
- Set clear goals and priorities for the labeling team, ensuring alignment with broader Regulatory Affairs and organizational strategies.

2. Labeling Planning & Execution:

- Oversee end-to-end labeling projects, from content creation and revisions to final implementation, ensuring on-time, in-full delivery of labeling materials.
- Coordinate across functions (e.g., Regulatory Affairs, Quality, Operations, Supply Chain) and regions to manage complex labeling changes and meet international requirements.
- Develop and manage project plans, defining timelines, milestones, and resources, and proactively identifying and mitigating potential risks or delays.

3. Compliance & Inspection Readiness:

- Ensure alignment with global regulatory requirements and company standards, maintaining consistent inspection readiness across labeling activities.
- Implement effective controls for tracking, auditing, and updating labeling content, ensuring accurate and compliant product information.
- Collaborate with Quality Assurance teams to address and close any compliance gaps or findings from audits, ensuring ongoing compliance.

4. Stakeholder Management:

- Manage relationships with external vendors, such as translation and artwork providers, by setting clear Service Level Agreements (SLAs) and key performance indicators (KPIs) to ensure optimal performance.
- Communicate effectively with global teams, regional affiliates, and third-party partners, maintaining transparency and driving successful outcomes across labeling processes.

5. Continuous Improvement & Systems Optimization:

- Identify and implement opportunities to enhance labeling workflows and processes, driving efficiencies and cost savings without compromising quality or compliance.
- Leverage technology, including Labeling Management Systems, to improve labeling accuracy, data integrity, and cross-functional visibility.
- Champion best practices, developing Standard Operating Procedures (SOPs), work instructions, and training materials to ensure quality and compliance in all labeling activities.

Basic Qualifications:

- Doctorate degree and 3 years of Pharmaceutical, Regulatory, or Quality Management experience OR
- Master's degree and 8 to 12 years of Pharmaceutical, Regulatory, or Quality Management experience OR
- Bachelor's degree and 12 to 14 years of Pharmaceutical, Regulatory, or Quality Management experience OR
- Diploma and 16 to 18 years of Pharmaceutical, Regulatory, or Quality Management experience.

Preferred Qualifications:

- Proficiency in project management and vendor oversight, ideally within a global or matrixed organization.
- Experience with electronic Labeling Management Systems, such as Veeva Vault or similar tools.
- Strong knowledge of global regulatory labeling requirements, including US, EU, and emerging markets.
- Strong analytical skills for troubleshooting, process mapping, and implementing continuous improvement initiatives in labeling and compliance processes.

Soft Skills:

- Excellent leadership, communication, and interpersonal skills.
- Ability to prioritize tasks in a fast-paced, dynamic environment.
- Problem-solving and decision-making skills with a focus on compliance and operational excellence.
- Ability to collaborate across multiple teams, aligning on global strategies and deliverables.
- Strong attention to detail and commitment to quality in all aspects of work.

What We Offer:

- Opportunity to lead and shape global labeling compliance initiatives in a highly dynamic and innovative environment.
- A collaborative, cross-functional working atmosphere that fosters professional growth and development.
- Competitive compensation, benefits, and flexibility for remote or hybrid work.
- The chance to make an impact in the biotech industry, ensuring compliance while driving continuous improvements in labeling and regulatory processes.

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