The VP Quality is responsible for leading the Quality function in Sharp's Bethlehem PA, Rhymney UK, Heerenveen NL, and Hamont BE clinical and commercial packaging operations. This position reports directly to the SVP Global Quality with a dotted line to the Managing Director, Sharp Clinical & Sharp Europe. The position has responsibility for leading the Pharmaceutical Quality System (PQS), implementing a Quality Maturity model that drives Quality Risk Management and embraces technology and innovation, fostering a Quality culture, improving customer satisfaction, and driving sustainable regulatory compliance. The heads of Quality at Sharp Bethlehem, Rhymney, Heerenveen, and Hamont will report directly to the VP Quality.
The VP Quality is responsible for driving alignment and harmonization across Quality operations in the clinical sites and for strengthening all four sites in accordance with Sharp's PQS strategy. The role includes partnering and collaborating with stakeholders across the EU/US Clinical and Commercial 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. The VP Quality will be a key and active member of the Global Quality Leadership team which drives Quality functional excellence.
The VP Quality will also serve as a member of the EU/US Clinical/Commercial Business Leadership Team and will share 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 include the following: (other duties may be assigned)
Provide Quality leadership across Sharp's Bethlehem PA, Rhymney UK, Heerenveen NL, and Hamont BE clinical and commercial packaging business. Drive the company's Quality strategy and culture and ensure that the Quality infrastructure, systems, people, processes, and practices are of a high standard and a competitive advantage for Sharp.
Drive a culture of Quality that is aligned with a global Quality Culture initiative. Progress Sharp's Quality strategy of enabling prevention by Quality Risk Management, trending/analysis of data and the use of leading indicators.
Lead and develop the functions of Quality Assurance, Quality Control, Quality Systems, Validation, Regulatory Affairs, and Compliance.
Drive a QP release function in support of a market release service offering.
Lead the alignment of Quality programs, processes, and practices with other parts of the global Quality organization. Drive the 'right-sizing' of Quality Systems to enable business excellence.
Lead the management of federal, state & international agency registrations, licenses, and regulatory filings as appropriate.
Ensure that the implemented electronic quality management system continues to meet the needs of the US/EU Commercial & Clinical Packaging business.
Partner with Operations and other key stakeholders to enable customer satisfaction, retention, and new customer acquisition, as it relates to Quality. Build strong, proactive relationships with customers.
Serve as a primary point of contact for Regulatory Agencies, as it pertains to the US/EU Commercial and Clinical Packaging business.
Provide routine data-driven measurements of the health of the Pharmaceutical Quality System (PQS).
Drive a functioning continuous improvement program as it pertains to the PQS.
Lead the development and optimization of the Quality organizations in the four US/EU Commercial and Clinical Packaging facilities, to enable Sharp's business and growth objectives.
Represent the US/EU Commercial and Clinical Packaging business at industry meetings and conferences and establish oneself as a subject matter expert by staying abreast of technical/regulatory/Quality advancements in the industry.
Manage a Quality budget.
Qualification and Experience
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 to do the job.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential
functions.
Bachelors' Degree or equivalent in pharmacy or a related field.
At least 15 years of progressive Quality leadership experience within the pharmaceutical/biotech manufacturing or packaging arena. Experience of working and managing an international site network is a distinct advantage.
Is a change agent with the ability to inspire organizations. Is passionate about continuous improvement and will work closely with stakeholders to ensure facilities operate at the highest level possible.
Has a customer-centric mentality, enjoys interacting with customers and drives the quality culture to be nimble and responsive.
Has strong business acumen and has the instincts and expertise to lead harmonization in a matrixed