Summary
The Senior Director of Quality Assurance & Compliance is responsible for leading the Quality Assurance & Compliance teams in our US Clinical manufacturing/packaging facility. Reporting directly to the VP Quality with a dotted line to the Clinical US General Manager, this position is responsible for leading the Pharmaceutical Quality System (PQS) across Sharp’s Clinical US facility, implementing a Quality Maturity model that embraces Quality Risk Management, fostering a Quality culture, improving customer satisfaction and driving sustainable regulatory compliance. The individual filling this role will be a key member of the Global Quality Leadership team and will drive alignment at the US Clinical site as it relates to Sharp’s PQS strategy.
The Senior Director of Quality Assurance & Compliance will partner and collaborate with stakeholders across the Clinical organization to right-size and improve internal processes and to strengthen Quality governance when assessing new product opportunities, supporting new customer/product onboarding, existing client base business and life cycle management activities. As a member of the Site Leadership Team, this position shares responsibility for improving operational and financial performance, ensuring effective communication and decision-making, strategically aligning, and managing resources, developing people, and increasing overall client satisfaction.
Essential Duties and Responsibilities
- Lead and develop a Quality team to deliver upon business goals.
- Develop policies & processes to enable compliance with relevant regulatory authorities and Sharp’s customers’ expectations.
- Identify and drive initiatives in support of fostering and enriching a Quality culture.
- Collaborate with functional peers in establishing and implementing cross-functional initiatives that drive regulatory compliance and enable the maturing of our PQS at Sharp.
- Collaborate with/support Clinical technical teams with new product/process opportunities.
- Delineate a clear definition of the Quality Unit’s role and responsibility and drive the ‘right-sizing’ of Quality Systems.
- Drive a strong training program and ensure that training effectiveness is measured and managed.
- Provide oversight of the batch record review and release process, ensuring timely and compliant execution.Lead a Validation Program that covers equipment qualification, cleaning validation and computer system validation.
- Lead the design and performance management of Quality Systems that cover complaint, non-conformance and CAPA management.
- Lead a cGMP internal audit process, to include focused and general audits of Operations, Logistics, Laboratories and Quality Assurance functions. Drive resolution and continuous improvement of identified deficiencies.
- Ensure effective management of customer escalations, and the timely and effective communication and resolution of issues that help drive customer satisfaction.
- Drive a robust Supplier Quality Management Program.
- Manage federal, state & international agency registrations, licenses, and regulatory filings as appropriate.
- Lead a robust Management Review process.
- Lead a PQS continuous improvement process.
- Stay abreast of technical/regulatory/Quality advancements in the industry.
- Manage a Quality budget.
- Other duties as assigned.
Qualifications
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below represent the knowledge, skill, and/or ability required.
- Bachelors’ Degree or equivalent in pharmacy or a related field.
- At least 7 years in the pharmaceutical/biotech manufacturing or packaging arena, in a Quality or Compliance role.
- 5+ years management experience leading Quality with medium sized teams.
- Experience of working and managing an international site network would be a distinct advantage.
- Has the ability to work independently, handle multiple tasks simultaneously and meet critical timelines.
- Has excellent oral and written communication skills.
- Is proficient in interpreting and educating on the cGMPs, FDA, EMA & DEA Regulations and associated regulatory guidance documents.
- Has strong leadership skills and has experience of mentoring/developing teams.
- Has a working knowledge of Microsoft Office Products, including Word, MS Project, Excel and PowerPoint.