Director, Quality Assurance and Compliance

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

➢ 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.

Travel to EU clinical facilities as required to drive alignment activities (between 1-2 trips per year)

➢ 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.