Executive Director, Quality & Compliance

June 29

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BioDuro-Sundia

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In Pursuit of Your Success

Discovery Chemistry • Integrated Services • Discovery Biology • Protein Expression and Purification • Assay Development

1001 - 5000

Description

• Establish and maintain a compliance program consistent with regulatory requirements and company policies. • Provide leadership and oversight to functional quality control areas and contract services. • Manage internal and external audits, regulatory inspections, and compliance activities. • Ensure the effectiveness of the Quality System and its compliance. • Support activities where product is developed, manufactured, tested, and distributed. • Monitor external regulations and create implementation strategies aligned with business goals. • Manage all aspects of Product Quality including Quality Systems, Assurance, and Control. • Ensure the Total Quality Management system and identify improvement projects. • Provide direction on quality policies and troubleshoot critical issues. • Develop talent and provide training within the organization to enhance quality culture. • Represent Quality in corporate management team and report on quality metrics and trends. • Maintain compliance with industry standard licenses and regulatory guidelines.

Requirements

• Minimum 15+ years of well-rounded Quality and Regulatory Compliance experience (Operations Quality a plus) in positions of increasing responsibility, with a preferred focus CMC. • Minimum 7+ years in a leadership capacity • Proven, recent corporate leadership experience within a pharmaceutical or CMO company • Clear ability to work effectively with relevant stake-holders cross-functionally to influence and impact operations. Highly collaborative and able to work through influence and negotiations creating win-win outcomes. • Demonstrated success navigating complex business environments and driving efficient and effective execution of programs. • Proven experience shoring up quality management systems and comprehensive audit programs. • Experience working directly with the FDA, Health Authorities and other governmental agencies on Regulatory Compliance matters. • Exceptional leadership skills with deep business acumen; proven ability to inspire, motivate and provide professional development to Quality professionals • Ability to inspire and build effective relationships with C-suite, peers, and ability to attract and retain a team by leading with inclusion and diversity that will motivate people to produce their best work. • Considerable experience and comfort with building rational strategies and defending your ideas with evidence to influence key decision makers. • Strong data-driven leader with deep expertise in reporting, project management, performance analysis, and prioritization skills. • Demonstrated success leading the change management efforts required when introducing new processes and evolving the capabilities of an organization. • Ability to organize logical arguments into well written final documents. • Strong verbal and written communication skills, proven ability to translate technical documentation into effective compliance documents

Benefits

• Full health benefits • Paid vacation and sick leave • Aggressive bonus structure • Market-competitive salaries • Engaging employee and community outreach events • Reward and promote employees exhibiting values of Accountability, Respect, Tenacity, Results and Integrity