What are the responsibilities and job description for the Senior Director Clinical Quality Assurance and Compliance position at Sharp Services?
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
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.
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.
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.