Job description

Clinigen Limited is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely, on time and wherever they are needed in the world.

We are currently 1,100 people, headquartered in the UK, with sites in Burton-on-Trent and Weybridge, with global offices in the US, EU, Australia, New Zealand, Japan, Hong Kong, South Africa, and South East Asia. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued growth. To sustain our growth, we’re on the lookout for motivated, ambitious and committed individuals to join our highly successful global team.

This position is to oversee, develop and establish the administration of effective quality systems, practices and procedures, while maintaining responsibility for coordinating activities relative to quality systems, quality improvement and compliance to quality standards.

Key Responsibilities:

• Mentor direct reports in their daily responsibilities
• Identify, evaluate and facilitate process improvements as an agent of change
• Promote, facilitate, approve, and maintain Quality Procedures
• Maintain current knowledge of regulations required to carry out the company’s activities
• Ensure the quality system is defined, documented, implemented and participate in evaluating its effectiveness through management review
• Oversee internal and external audit program(s) ensuring adequate follow-up from previous audit(s) is completed, whenever applicable
• Utilize a systems based approach to manage, facilitate and support the Deviation, Complaint and CAPA program(s)
• Function as Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives
• Cultivate integrated working relationship with employees and other departments to establish quality standards
• Responsible for the overseeing the development and administration of the Employee GMP Training Program
• Partner with Human Resources to hire/train/coach/develop and evaluate employees and provides timely and compliant employee counseling as discipline and termination issues arise
• Communicate operational and personal concerns, and opportunities for improvement to department leaders
• Take responsibility for personal skill development in continuing to learn current pharmaceutical standards and industry trends
• Know, understand and comply with the company’s standard operating procedures and policies
• To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures
• Perform other related job duties or responsibilities as assigned

What You Bring To The Role:

• Bachelor’s Degree in Biology, Chemistry, Pharmacy, or related Science
• 5-8 yeas of experience ensuring quality within a related field
• Experience in a supervisory capacity
• Working knowledge of GMPs, GCPs, CFR, EU directives and ICH guidelines
• Experience in creating and implementing a quality system
• Ability to assess departmental policies and procedures and propose changes that yield the best quality improvement return for the time and effort invested
• Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style
• Ability to train and mentor others in continuous process improvements
• Self-motivated with exceptional time management skills to prioritize work and efficiently react to change in a fast-paced environment
• Maintain a high regard for confidentiality while dealing with all clients, proprietary and pharmaceutical related information

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical, Biotech, or Healthcare Industry: 5 years (Required)
• Quality Assurance: 5 years (Required)

Work Location: Hybrid remote in Malvern, PA 19355

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