Director, Clinical Quality Assurance
4 weeks ago
JPC Partners is looking for a Director of Quality Assurance & Compliance that will be responsible for leading the Quality Assurance & Compliance teams in the US Clinical manufacturing and packaging facility. The role will be a key member of the global Quality team and take a leading role in ensuring alignment across three (3) clinical sites as it relates to the PQS strategy. This role will partner and collaborate with stakeholders across the organization to improve internal processes and governance around assessing new product opportunities, customer/product onboarding, ongoing client support, and life cycle management. As a member of the local site leadership team, this position shares responsibility for improving operational and financial performance, improving communication and decision management, creating and maintaining a flexible workforce, strategically aligning and managing resources, creating development and promotional opportunities for colleagues and direct reports and increasing overall client satisfaction. ESSENTIAL DUTIES AND RESPONSIBILITIES Develop policies and processes to enable compliance with FDA and all competent authority regulations and requirements. Identify and drive initiatives in support of fostering a Quality culture. Lead and develop the Quality team through regular coaching and by establishing and implementing performance measures. Collaborate with functional peers to establish cross-functional initiatives, development of operating procedures and shared goals. Ensure the Quality unit delineates clear roles and responsibility and drives the 'right-sizing' of Quality Systems. Drive a strong training program and ensure that training effectiveness is measured and managed. Lead the review and release of batch records. Manage a Quality budget. Manage a Validation program including equipment qualification and computer system validation. Manage the review and approval of complaints, non-conformances and recommend corrective and preventative actions. Lead a cGMP audit process, to include focused and general audits of Operations and Quality Assurance areas. Ensures resolution of any identified issues. Ensure effective management of customer escalations, and timely and effective communication and resolution of issues that help drive customer satisfaction. Ensure a robust Supplier Quality Program. Manage federal, state and international agency registrations, licenses and regulatory filings as appropriate. Lead a Management Review process. Lead a PQS continuous improvement process. Collaborate with and support technical teams about new product/process opportunities. Review technical and regulatory publications and abstracts to stay abreast of technical and Quality developments in the industry. Monitor the external environment and identify opportunities for improvement. Travel to EU clinical facilities as required to drive alignment activities (between 1-2 trips per annum) QUALIFICATIONS 7+ years in pharmaceutical or biotech manufacturing or packaging in a Quality or Compliance role. 3 - 5 years management experience leading medium size teams. Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines. Excellent oral and written communication is required to communicate with the team, peers, management and external contacts. Proficient with interpreting and implementing cGMPs, FDA & DEA Regulations and CFRs. Strong leadership skills to mentor and develop team to achieve Company goals. Working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel. Bachelors' Degree or equivalent in pharmacy or related field
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Director, Quality Assurance
2 weeks ago
Bethlehem, United States Sharp Clinical Services Full timeThe Director of Quality Assurance & Compliance is responsible for leading the Quality Assurance & Compliance teams in our US Clinical manufacturing and packaging facility. Reporting directly to the SVP Global Quality with a dotted line to the General Manager, the position is responsible for leading the Pharmaceutical Quality System (PQS) in Sharp’s...
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Director, Clinical Quality Assurance
1 month ago
Bethlehem, United States JPC Partners Full timeJPC Partners is looking for a Director of Quality Assurance & Compliance that will be responsible for leading the Quality Assurance & Compliance teams in the US Clinical manufacturing and packaging facility. The role will be a key member of the global Quality team and take a leading role in ensuring alignment across three (3) clinical sites as it relates to...
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Director, Clinical Quality Assurance
6 hours ago
Bethlehem, United States JPC Partners Full timeJPC Partners is looking for a Director of Quality Assurance & Compliance that will be responsible for leading the Quality Assurance & Compliance teams in the US Clinical manufacturing and packaging facility. The role will be a key member of the global Quality team and take a leading role in ensuring alignment across three (3) clinical sites as it relates to...
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Director, Clinical Quality Assurance
1 week ago
Bethlehem, United States Sharp Corporation Full timeThe Director of Quality Assurance & Compliance is responsible for leading the Quality Assurance & Compliance teams in our US Clinical manufacturing and packaging facility. Reporting directly to the SVP Global Quality with a dotted line to the General Manager, the position is responsible for leading the Pharmaceutical Quality System (PQS) in Sharp's flagship...
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Director, Clinical Quality Assurance
1 week ago
Bethlehem, United States Sharp Services Full timeThe Director of Quality Assurance & Compliance is responsible for leading the Quality Assurance & Compliance teams in our US Clinical manufacturing and packaging facility. Reporting directly to the SVP Global Quality with a dotted line to the General Manager, the position is responsible for leading the Pharmaceutical Quality System (PQS) in Sharp's flagship...
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Director, Clinical Quality Assurance
11 hours ago
Bethlehem, United States Sharp Services Full timeThe Director of Quality Assurance & Compliance is responsible for leading the Quality Assurance & Compliance teams in our US Clinical manufacturing and packaging facility. Reporting directly to the SVP Global Quality with a dotted line to the General Manager, the position is responsible for leading the Pharmaceutical Quality System (PQS) in Sharp's flagship...
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Quality Assurance Supervisor
1 week ago
Bethlehem, Pennsylvania, United States Michael Page Full timeAbout Our Client Located in Bethlehem, PA area, the global manufacturing firm specializes in producing high-quality industrial components for diverse industries worldwide. With state-of-the-art facilities and advanced technology, we maintain a competitive edge in the market. Our commitment to innovation and excellence drives our continuous improvement...
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Quality Assurance Supervisor
15 hours ago
Bethlehem, Pennsylvania, United States Michael Page Full timeAbout Our Client Located in Bethlehem, PA area, the global manufacturing firm specializes in producing high-quality industrial components for diverse industries worldwide. With state-of-the-art facilities and advanced technology, we maintain a competitive edge in the market. Our commitment to innovation and excellence drives our continuous improvement...
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UIG - Quality Assurance Supervisor
1 week ago
Bethlehem, United States Nucor Corporation Full timeJob DetailsDivision: Universal Industrial Gases, LLCLocation: Bethlehem, PA, United States Other Available Locations: Arkansas; Kentucky; South Carolina; West VirginiaBasic Job Functions:Universal Industrial Gases, LLC. (UIG) is a wholly owned subsidiary of Nucor and a well-established, global engineer, constructor, supplier and operator of air separation...
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UIG - Quality Assurance Supervisor
1 week ago
Bethlehem, United States Fisher & Ludlow Div Of Harris Steel Ltd. Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Select how often (in days) to receive an alert: Other Available Locations: Arkansas; Kentucky; South Carolina; West Virginia Basic Job Functions: Universal Industrial Gases, LLC. (UIG) is a wholly owned subsidiary of Nucor and a well-established, global...
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UIG - Quality Assurance Supervisor
1 week ago
Bethlehem, United States Universal Industrial Gases, LLC Full timeJob Details Division: Universal Industrial Gases, LLC Location: Bethlehem, PA, United States Other Available Locations: Arkansas; Kentucky; South Carolina; West Virginia Basic Job Functions: Universal Industrial Gases, LLC. (UIG) is a wholly owned subsidiary of Nucor and a well-established, global engineer, constructor, supplier and...
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UIG - Quality Assurance Supervisor
1 week ago
Bethlehem, United States Nucor Corporation Full timeJob Details Division: Universal Industrial Gases, LLC Location: Bethlehem, PA, United States Other Available Locations: Arkansas; Kentucky; South Carolina; West Virginia Basic Job Functions: Universal Industrial Gases, LLC. (UIG) is a wholly owned subsidiary of Nucor and a well-established, global engineer, constructor, supplier and operator of air...
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Quality Assurance INTERN
12 hours ago
Bethlehem, United States Just Born Full timeWe're looking for a summer Quality Assurance Intern to join our team. This role offers a great opportunity to gain professional experience in your field of interest. The selected student will work under the direction of various Technical Services and Supply Chain team members, as well as independently, on a variety of tasks and robust projects that...
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Quality Assurance Supervisor
1 week ago
Bethlehem, United States Michael Page Full timeAs a Quality Assurance Supervisor at the global manufacturing firm located in the Bethlehem, PA area, you will oversee the implementation and maintenance of quality standards across all manufacturing processes. Your responsibilities will include developing and enforcing quality control procedures to ensure products meet both internal and external standards. ...
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Quality Assurance Supervisor
5 hours ago
Bethlehem, United States Michael Page Full timeAs a Quality Assurance Supervisor at the global manufacturing firm located in the Bethlehem, PA area, you will oversee the implementation and maintenance of quality standards across all manufacturing processes. Your responsibilities will include developing and enforcing quality control procedures to ensure products meet both internal and external standards. ...
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Clinical Director
1 month ago
Bethlehem, United States Surgery Partners Full timeThe Clinical Director will: Supervise staff, coordinate personnel actions for sub-department unit staff and/or faculty, oversee records and filing systems, control equipment and supplies and coordinate automated information systems and facilities and space planning for operations. In addition, the incumbent will participate in the development and operation,...
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Clinical Director
5 hours ago
Bethlehem, United States Surgery Partners Full timeThe Clinical Director will: Supervise staff, coordinate personnel actions for sub-department unit staff and/or faculty, oversee records and filing systems, control equipment and supplies and coordinate automated information systems and facilities and space planning for operations. In addition, the incumbent will participate in the development and operation,...
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Director, Medical Director
2 months ago
Bethlehem, PA, United States St. Luke's University Health Network Full timeLukes University Health Network , the regions largest, most established health system is seeking a Medical Director to lead the Breast Program in a multidisciplinary setting. Qualified candidates must have a proven clinical, research and administrative track record and is interested in leading our Breast Program, the team currently has 3 dedicated breast...
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Director, Medical Director
2 months ago
Bethlehem, PA, United States St. Luke’s University Health Network Full timeLuke’s University Health Network, the region’s largest, most established health system is seeking a Medical Director to lead the Breast Program in a multidisciplinary setting. Qualified candidates must have a proven clinical, research and administrative track record and is interested in leading our Breast Program, the team currently has 3 dedicated...
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Medical Director of the Breast Program
2 months ago
Bethlehem, United States St. Lukeâs University Health Network Full timeSt. Luke s University Health Network, the region s largest, most established health system is seeking a Medical Director to lead the Breast Program in a multidisciplinary setting. Qualified candidates must have a proven clinical, research and administrative track record and is interested in leading our Breast Program, the team currently has 3 dedicated...