Director, Clinical Quality Assurance - Bethlehem, United States - Sharp Corporation

Description

Director, Global Quality Assurance & Compliance page is loaded

Director, Global Quality Assurance & Compliance

Apply locations Bethlehem time type Full time posted on Posted 6 Days Ago job requisition id JR29581

SUMMARY

The Director of Quality Assurance & Compliance is responsible for leading the Quality Assurance & Compliance teams in the US and UK Clinical manufacturing and packaging facilities. Reporting directly to the SVP Global Quality with a dotted line to the Managing Director of Sharp Clinical and Sharp Europe, the position is responsible for leading the Pharmaceutical Quality System (PQS) in Sharp's Clinical business, driving a culture of Quality at each facility to enable a Quality maturity model that focuses on prevention, harmonizing Quality systems and practices to create efficiencies, improving customer satisfaction and driving sustainable regulatory compliance.

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 Sharp Clinical Senior Leadership Team (SLT), 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 quality standards be in compliance with FDA and all competent authority regulations and requirements.
• Enable cGMP compliance by fostering and driving a Quality culture.
• Lead, mentor and develop the Quality team through regular coaching and by establishing and implementing performance measures.
• Collaborate with other management personnel in formulating and establishing company policies, operating procedures, goals, and other initiatives.
• Ensure the quality assurance program delineates clear areas of responsibility and 'right-sized' Quality Systems.
• Drive a strong training program and ensure that training effectiveness is measured.
• Lead the review and release of batch records.
• Manage a Quality Assurance budget.
• Manage a Validation program including equipment qualification and computer system validation
• Manage the review and approval of complaints and non-conformances and recommend corrective and preventative actions.
• Lead the audit process, including focused and general audits of Operations and Quality Assurance areas against cGMP standards. Ensures resolution of any identified issues.
• Ensure effective management of customer escalations, addressing issues, and ensuring timely and effective communication and resolutions that help drive customer satisfaction.
• Ensure a robust Supplier Quality Program.
• Manage federal, state and international agency registrations, licenses, regulatory filings as appropriate.
• Lead a Management Review process across both clinical facilities.
• Lead a PQS continuous improvement process.
• Collaborate with and support technical teams about new product/process opportunities.
• Review technical and regulatory publications, articles, and abstracts to stay abreast of technical and Quality developments in the industry.
• Monitor the external environment and identify opportunities to fulfill the corporate quality strategy.
• Travel to EU facilities (between 2-4 trips per annum).
• Other duties as assigned.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelors' Degree or equivalent in pharmacy or related field.
• At least 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.

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About Us

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry.

We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands.

We've built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products.

Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery.

Our clinical services division is one of the world's leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.

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