Quality Control System Support Compliance Sr. Associate/Manager - United States
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain company's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
- The QC System Support Manager or Associate will be responsible for improvement, development, design, implementation and maintenance of quality systems and compliance initiatives for the QC Laboratory areas.
- The role will initially be focused on the identification of gaps and addressing the issues associated with the laboratory lab processes and harmonizing where possible.
- Develop and implement continuous improvement projects for the QC quality systems
- Represent QC on cross-functional teams which address quality issues and system improvements
- Improve and develop standard operating procedures in support of QC initiatives
- Establish and track quality metrics for the laboratories
- Analyze trends relating to discrepancy metrics and identify necessary quality adjustments
- Facilitate closure of discrepancy records to meet on-time closure rates
- Improve and participate in the oversight of internal quality systems
- Design and implementation of CAPA records involving lab improvements
- Review, assess and distribute compendial changes to all company sites.
- Identify compliance gaps and work towards resolution
- Interface with regulatory agencies
- Review and approve QC discrepancy records
- Manager level requires 8+ years in a GMP environment (Pharmaceutical or Diagnostics/Device industry)
- Sr. Associate level requires 6+ years in a GMP environment
- Associate level requires 4+ years in a GMP environment
- Good verbal, written, interpersonal, organizational and communication skills.
- Experience with Deviation/CAPA, Change Control and Good Documentation Practices
- Ability to meet deadlines and multi-task efficiently
- Comfortable in a fast paced environment with changing priorities
- Proficient with Microsoft Office Suite, Word, Excel and PowerPoint
- Knowledgeable in global regulatory requirements and guidelines
- Broad understanding and experience in pharmaceutical GXP
- Experience in preparing for and participating in regulatory inspections
- Experience with identifying issues, diving change and improvements and streamlining processes
- Laboratory experience and/or experience with analytical methods
Role will interact with internal and global QC laboratory personnel, Quality Assurance, Manufacturing, Regulatory Affairs, Compliance and Facilities.