- 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 in 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 n 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)
- Other duties as assigned.
- 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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Director, Clinical Quality Assurance - Bethlehem, United States - Sharp Corporation
Description
The 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 Clinical site, implementing a Quality maturity model that focuses on prevention, fostering a Quality culture, improving customer satisfaction and driving sustainable regulatory compliance. The role will be a key member of the global Quality team and take a leading role in ensuring alignment across our three (3) clinical sites as it relates to our 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
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, reach with hands and arms and stoop, kneel, or crouch. The employee is regularly required to sit and talk or hear. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include color, peripheral and distance vision and the ability to adjust focus. Must be willing to travel up to 25% (domestic and international). Will be required to travel by automobile, plane, train or other forms of public transportation. Must be able to assess, navigate, and exchange accurate information to arrive at and depart from various locations to conduct business. Ability to uphold the stress of traveling.
