SK Pharmteco
Director of Quality Assurance
SK Pharmteco, King of Prussia, Pennsylvania, United States,
Position Summary:SK Pharmteco is looking for an experienced leader to support commercial operations at the site by establishing and optimizing quality systems, driving growth, and ensuring quality across site operations. This role will provide leadership, strategic thinking, and requires a results focus mindset to reliably meet and/or exceed the site’s performance targets and client demands while achieving high levels of quality, compliance, and safety. This position requires an individual capable of partnering across the organization to manage a fast-paced environment and deliver exceptional service to our clients.
Primary Responsibilities:
Interpret industry regulations and guidance documents for the creation, implementation, and optimization of quality standards, policies, and site procedures.
Lead Pre-Approval Inspection and Pre-Licensing Inspection activities.
Provide quality oversight and leadership for tech-transfer and process validation programs.
Lead commercialization initiatives providing clear, consistent leadership, management, and mentoring.
Provide technical expertise to internal and external customers.
Facilitate problem-solving, contingency planning, and decision-making for the matrixed facilities, CMC, quality and supply chain teams.
Data analysis - able to collect and analyze data to identify trends and detect problems and key issues.
Judgment and problem-solving - able to define decision criteria and determine the most appropriate course of action.
Planning and organizational skills - able to establish objectives and schedule tasks and resources efficiently.
Communication skills - strong written communication skills to provide concise and clear documentation.
Partner with other business units or departments in support of continuous improvement initiatives.
Author or revise SOPs to address gaps or necessary improvements to Quality Systems.
Develop and provide cGMP and other GxP training as needed.
Review the implementation, execution and effectiveness of the quality systems and inspection processes e.g., documentation of internal audits and other quality assurance activities, investigations, customer complaints, CAPA’s and non-conformance issues.
Maintain knowledge of global regulatory requirements for the Cell and Gene Therapy products.
Responsible for authoring quality lifecycle management documents of facilities, processes and equipment and using appropriate quality systems for implementation and maintenance.
Develop and maintain systems that ensure the technical and regulatory competency of personnel within the organization.
Interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging and release of manufacturing products as needed.
Foster a Quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.
Manage problems of varied scope using a high degree of prudence and risk-based decision making.
Develop, motivate, and lead teams of cross-functional resources in a matrixed organization with competing priorities.
Additional duties as assigned.
Education & Experience:
Bachelor's Degree in a commercial or scientific field required, advanced degree MS, PhD or MBA preferred.
Minimum of 10+ years of progressive managerial experience within biopharmaceutical Quality Assurance. Cell and Gene Therapy industry experience is a plus.
10+ years’ in-depth experience in GMP/GXP industry. (12+ for Dir level)
In-depth knowledge of risk management systems and/or computer systems validation programs strongly preferred e.g. Veeva, Labware (LIMS), SAP.
Previous experience preparing for and leading regulatory inspections, facility design, commissioning and qualification.
A hands-on leader who can perform day-to-day QA, Facility, and Safety related activities as well as direct others to perform such work.
Physical Requirements:
Must have the ability to gown in a clean room environment and apply required PPE for some period to perform audits, GEMBA walks, and tours.
Ability to sit for periods of time viewing a computer workstation.
Ability to lift up to 15lbs at times.
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Primary Responsibilities:
Interpret industry regulations and guidance documents for the creation, implementation, and optimization of quality standards, policies, and site procedures.
Lead Pre-Approval Inspection and Pre-Licensing Inspection activities.
Provide quality oversight and leadership for tech-transfer and process validation programs.
Lead commercialization initiatives providing clear, consistent leadership, management, and mentoring.
Provide technical expertise to internal and external customers.
Facilitate problem-solving, contingency planning, and decision-making for the matrixed facilities, CMC, quality and supply chain teams.
Data analysis - able to collect and analyze data to identify trends and detect problems and key issues.
Judgment and problem-solving - able to define decision criteria and determine the most appropriate course of action.
Planning and organizational skills - able to establish objectives and schedule tasks and resources efficiently.
Communication skills - strong written communication skills to provide concise and clear documentation.
Partner with other business units or departments in support of continuous improvement initiatives.
Author or revise SOPs to address gaps or necessary improvements to Quality Systems.
Develop and provide cGMP and other GxP training as needed.
Review the implementation, execution and effectiveness of the quality systems and inspection processes e.g., documentation of internal audits and other quality assurance activities, investigations, customer complaints, CAPA’s and non-conformance issues.
Maintain knowledge of global regulatory requirements for the Cell and Gene Therapy products.
Responsible for authoring quality lifecycle management documents of facilities, processes and equipment and using appropriate quality systems for implementation and maintenance.
Develop and maintain systems that ensure the technical and regulatory competency of personnel within the organization.
Interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging and release of manufacturing products as needed.
Foster a Quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.
Manage problems of varied scope using a high degree of prudence and risk-based decision making.
Develop, motivate, and lead teams of cross-functional resources in a matrixed organization with competing priorities.
Additional duties as assigned.
Education & Experience:
Bachelor's Degree in a commercial or scientific field required, advanced degree MS, PhD or MBA preferred.
Minimum of 10+ years of progressive managerial experience within biopharmaceutical Quality Assurance. Cell and Gene Therapy industry experience is a plus.
10+ years’ in-depth experience in GMP/GXP industry. (12+ for Dir level)
In-depth knowledge of risk management systems and/or computer systems validation programs strongly preferred e.g. Veeva, Labware (LIMS), SAP.
Previous experience preparing for and leading regulatory inspections, facility design, commissioning and qualification.
A hands-on leader who can perform day-to-day QA, Facility, and Safety related activities as well as direct others to perform such work.
Physical Requirements:
Must have the ability to gown in a clean room environment and apply required PPE for some period to perform audits, GEMBA walks, and tours.
Ability to sit for periods of time viewing a computer workstation.
Ability to lift up to 15lbs at times.
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