DIRECTOR, CLINICAL QUALITY ASSURANCE
2 weeks ago
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)
- 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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