Associate Director - Quality

6 hours ago

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CSL

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Complex biologicals • vaccines • plasma and plasma derived therapeutics • biotechnology

10,000+ employees

Founded 1916

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 $111M Post-IPO Equity on 2004-02

Description

• Ensure center processes conform to Quality standards by collaborating and communicating with staff. • Assist Center Leadership in audit preparation. • Provide oversight of employee related issues including decisions for hiring and employee relations. • Direct Assistant manager of quality and Center Leadership through investigations and problem-solving events. • Responsible for management and quality approval of deviations. • Develop & maintain process to disseminate quality interpretation & strategies to operationalize relevant regulations, guidance’s & standards. • Support facility maintenance to highest safety, compliance, and cleanliness standards. • Develop strategies to maintain stable operations during emergent situations.

Requirements

• Bachelor’s degree in biological science, management or other medically related field required. • MBA and professional regulatory affairs certification preferred. • ASQ Quality Certification preferred. • Minimum 4 years management experience, including managing employees required. • Experience managing multi-site locations preferred. • Minimum of 4 years relating to quality or regulatory experience required. • Strong knowledge of GMP/GxP. • Excellent troubleshooting skills combined with calm demeanor that is successful in working with external organizations in resolving significant Quality issues required. • Demonstrated ability to successfully negotiate resolution of complex Quality issues. • Proven ability to engage others, concisely communicate complex situations and plans under stressful circumstances in a manner that facilitates successful and timely resolution. • Experience with regulatory authorities and international inspections. • Excellent critical reasoning, decision-making, and problem-solving skills to analyze situations, determine risks, find solutions to prevent future issues and resolve recurring defects. • Strong organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives. • Strong leadership, written and verbal communication, interpersonal and presentation skills to drive results. • Maintain company technical training certification, current professional licensure, or certification. • Advanced Knowledge and comprehension of ever-changing and complex government and industry regulations, and ability to monitor compliance remotely with these regulations. • Proficient in English. • Ability to interact and influence regulatory agencies/auditors as necessary.

Benefits

• Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage. • Company-provided basic life insurance and Short- and Long-Term Disability. • The option to participate in CSL’s 401(k) Savings Program. • Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business. • Paid observed holidays as designated by the Company.