Director/Sr. Director of Quality Assurance

RESPONSIBILITIES: MAIN PURPOSE OF JOB (BRIEF SUMMARY)

Lead Quality Assurance person that is responsible for leadership and direction for all aspects of GxP quality and quality control including compliance for internal and contract sites. MAIN JOB DUTIES/RESPONSIBILITIES

• Develop, implement and manage the Global Strategy and Systems in collaboration with Regulatory, Technical Services, 3rd party contract partners and Corporate Business strategy. • Direct and oversee the QA/QC Department • Lead quality input on contracts and is the primary contact for quality agreement negotiation. • Promote and advance quality awareness throughout the company. • Mentor and lead staff to achieve company objectives and ensure compliance. • Develop and manage quality budget. • Ensure that quality activities in support of corporate initiatives are adequately staffed and ensure that timelines are met in a quality manner. • Report critical non-compliance to management and collaborating with Corporate Compliance for Corporate Compliance Inspections • Act as source of advice and guidance on quality/GxP issues. • Leading the internal and external audit programme to verify compliance with GxP, and to determine the effectiveness of the Company’s quality systems and procedures • Ensure new contract organizations are assessed for GxP compliance and certified prior to supply of services and or goods. • Oversee disposition of commercial and clinical products to meet both company and regulatory requirements for domestic and global commerce. • Ensure a system operates effectively to manage change control, OOS’s, complaints, CAPAs and deviations • Assess non-conformities and non-compliant findings, and ensuring appropriate actions are agreed and effectively followed up – implementation and management of CAPA system. • Accept assigned ad hoc projects as required and work with groups both local and global to ensure delivery. • Co-ordinate with the FDA and other external auditors and customers to build trust and confidence in the company’s quality systems. • Assure appropriate standards are applied for IT, cleaning, equipment and method validation activities at contract sites and internally.

EDUCATIONAL BACKGROUND: • Bachelor’s degree or Master’s degree in technical discipline such as engineering or physical sciences. • Minimum of 10 years QA and auditing in a CDER regulated environment. • Small molecule quality experience a must.

REQUIRED EXPERIENCE: • 10 years of quality experience; 5 of which have been in a management position • Experience with FDA and regulatory inspections. • Experience in commercial operations. • Small molecule quality experience a must

ADDITIONAL INFORMATION: SKILLS/COMPETENCIES • Superior management, analytical and strategic and decision making skills • Strong interpersonal skills • Strong mentoring abilities • Proven track record of building effective internal and external partnerships • Ability to work effectively within cross-disciplinary teams and with vendors • Creative problem solver and keen ability to address current and anticipated issues • Self-starter with high energy level and strong results orientation