Manager - Project Management

Position Title:

Job Overview:

The Manager - Project Management is responsible for planning, coordinating, and overseeing cross-functional projects related to analytical, sourcing, manufacturing, and quality assurance activities. This role ensures timely execution, resource optimization, and alignment with business objectives while adhering to regulatory standards. The position demands leadership in managing project teams, mitigating risks, and fostering collaboration across departments to deliver successful project outcomes.

Key Responsibilities:

1. Project Planning and Coordination:

• Develop comprehensive project plans, including timelines, milestones, and resource allocation for analytical, sourcing, manufacturing, and quality assurance projects.
• Coordinate with cross-functional teams (e.g., R&D, QA, QC, Manufacturing, and Sourcing) to ensure seamless execution of projects.

2. Stakeholder Management:

• Act as the primary point of contact for project-related communication with internal and external stakeholders.
• Facilitate regular meetings to update stakeholders on project progress, challenges, and milestones.

3. Regulatory Compliance:

• Ensure all project activities align with regulatory standards such as GMP, FDA, and ICH guidelines.
• Collaborate with QA and Regulatory Affairs teams to address compliance requirements during project execution.

4. Risk Management:

• Identify potential risks in project execution and develop contingency plans to mitigate them.
• Monitor project performance to preempt delays or quality issues.

5. Resource Management:

• Allocate and manage resources effectively to meet project deadlines and objectives.
• Optimize the use of manpower, equipment, and budget to achieve project goals.

6. Documentation and Reporting:

• Oversee the preparation and maintenance of project documentation, including timelines, budgets, status reports, and risk assessments.
• Provide regular updates and detailed reports to senior management on project progress and outcomes.

7. Team Leadership:

• Lead and mentor project team members, fostering a culture of accountability and collaboration.
• Ensure team members are aligned with project goals and provide training/support as needed.

8. Continuous Improvement:

• Identify opportunities to enhance project management practices, streamline processes, and improve efficiency.
• Stay updated on industry trends and best practices in project management.

9. Budget Control:

• Monitor project budgets to prevent cost overruns and ensure financial discipline.
• Track procurement and resource expenditures, ensuring alignment with financial targets.

Key Skills:

Technical Skills:

• Proficiency in project management tools and methodologies (e.g., MS Project, Primavera).
• Strong understanding of pharmaceutical processes, including sourcing, manufacturing, quality assurance, and analytical activities.
• Knowledge of regulatory standards (e.g., GMP, FDA, ICH).

Soft Skills:

• Strong organizational and time management skills to handle multiple projects.
• Excellent communication and interpersonal skills for collaboration with stakeholders and teams.
• Problem-solving and decision-making abilities to address challenges and ensure project success.

Qualifications & Experience:

• Education:

  Bachelors or Master’s degree in Pharmacy, Chemistry, Project Management, or a related field.

• Experience:

• 10-15 years of experience in project management within pharmaceutical or biotech industries.
• Proven track record of managing cross-functional projects in a regulated environment.

• Certifications (Preferred):

  PMP, PRINCE2, or equivalent certification in project management.