Manager of Quality and Compliance
18 hours ago
Catalent, a global leader in the pharmaceutical industry, is seeking a skilled Manager of Quality and Compliance to join their team. With a strong focus on quality and compliance, this role will play a crucial part in ensuring the success of our clients.
About Us: Catalent is a leading partner for the development and manufacturing of new treatments for patients worldwide. Our mission is to help people live better, healthier lives.
Salary: $140,000 - $200,000 per year
Job Description:
We are looking for an experienced Quality and Compliance Manager to lead our quality and compliance team. As a key member of our operations team, you will be responsible for ensuring the timely and accurate execution of technical documentation for clinical packaging activities. This includes building and maintaining a high-performing team, managing work allocation and planning, and making independent leadership decisions to mitigate risks daily.
Responsibilities:
* Lead and manage the closure of all Corrections/Tasks and other Track Wise system reports for timely resolution and closure.
* Lead the review of SOPs, cGMP documentation, Batch Records, product related technical information, protocols, to ensure compliance with regulatory agencies and Company procedures.
* Provide direct support for customer/regulatory audits and responses to those audits.
* Mentor, train and coach staff in establishing effective studies with appropriate risk management.
* Work directly with Quality Assurance, Engineering, and Project Management functional areas to plan and implement documentation and training requirements for GMP (Good Manufacturing Practice) activities in manufacturing for clinical packaging operations.
Requirements:
* A Strong background in Quality and clinical supply management.
* Proven track record of driving results and change management with excellent communication skills.
* Pharmaceutical packaging and manufacturing experience preferred.
* ERP systems expertise preferred including JDEdwards, Fusion, Clinicopia, and other platforms.
* Demonstrated ability to supervise professional, technical associates, peers and non-direct reporting staff.
* Excellent interpersonal and communication skills.
* Computer literate (proficient in Microsoft Office Suite products).
* Knowledge of cGMPs, and all applicable country, state, and local rules and regulations.
* Leadership and team building skills.
Benefits:
* Annual Salary: $140,000 - $200,000
* Pension
* Life Assurance
* Bupa Healthcare
* Opportunities to join Employee Resource groups and be involved in charity events.
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