Vice president of quality

Employment Type

: Full-Time

Industry

: Miscellaneous



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Pharmasol is a small to midsize privately held contract development and manufacturing organization (CDMO) of personal care and pharmaceutical products for prominent global marketers and retailers. Our strong management team, continuous improvement philosophy and dedication drive our product quality and customer service. We currently have an opening for a Vice President of Quality. Job Summary: This is the most senior Quality leadership role at Pharmasol, a pharmaceutical liquid and semi-solid development and manufacturing organization. The primary purpose of this position is to lead the quality system structure to support the company’s strategic plan, future growth, improved customer expectations and regulatory compliance. This position will develop the vision and strategy for Quality and Regulatory Affairs, and set the standard for the overall quality environment at Pharmasol. The position will develop, manage, and lead the quality assurance function, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality outcomes for Pharmasol. This role will develop and implement effective, robust quality management system (QMS) processes and methods in alignment with FDA CFR 210, 211as well as 820 requirements, and will utilize metrics to continually improve quality processes and efficiency. Accountabilities & Responsibilities Main point of contact for the FDA site audits, responses, and all communication with all regulatory bodies. Develop, deploy and execute quality policies, objectives and plans that align and support the corporate strategic business goals. Creates long-range quality plans for the organization focusing on the effective development of new and establishing systems to ensure life-cycle management of products. Interact effectively and transparently with functional heads within pharmaceutical Development, and with other Pharmasol stakeholders (Quality, Commercial Manufacturing, Project Leadership, Business Development, Production Management, etc.). Hold reviewer/approver responsibility for appropriate CMC sections of regulatory submissions. Provides strategic direction on Quality initiatives to Leadership, and drives implementation throughout the organization. Plans and directs resources and activities that support the quality management system and quality assurance team. Identify and initiate improvements to the quality management system, ensuring compliance to all relevant quality standards and regulatory requirements. Monitor and audit the quality management system processes for compliance, effectiveness, and continued alignment with applicable regulatory and statutory requirements. Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate. Develop and maintain quality system dashboards, scorecards/key performance indicators for the quality system processes. Review and monitor trends during Management Review Meetings. Manage external quality and regulatory relationships with the FDA, other regulators and Notified Bodies. Maintains safe and ethical business practices and adheres to Pharmasol’s Quality Policy, ensuring that it is fully embraced across the organization and that initiatives are established for adherence to the Quality Policy at all levels of the organization. Provides guidance and direction on Quality initiatives and improvement processes and good manufacturing practices (GMP) across Pharmasol in support operations, meet Company goals and improve customer expectations. Establishes key relationships with strategic customer partners and peers. Provides leadership and guidance in the event of a recall or field action. Interface with facilities, regulatory agencies, and customers to address issues identified for improvement or resolution. Performs other duties as required. Reports to the President. Qualifications Skills/Knowledge Required: Bachelor’s degree in related science or similar technical discipline is required. Master’s degree is preferred. Experience working in FDA-regulated industry. Hands on experience with the FDA inspections and communication with regulators Solid understanding and proven leadership ability to align, motivate and empower team members Experience in budget management, and managing scientific staff from a budgetary and personnel standpoint Demonstrated ability for critical thinking, problem solving and innovation Effective communication, collaboration and negotiation Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment Potential to take on increasing responsibilities as the pharmaceutical portfolio and organization expands 15 years’ experience in Quality Assurance and Regulatory Affairs. Progressive and proven record of leadership with experience managing quality and regulatory functions in a pharmaceutical company. Experience with all phases of product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization a plus. 10 years of experience and success providing direct leadership and mentorship to a team of employees. Pharmasol is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pharmasol complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pharmasol in the U.S.

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