Associate Director Quality

The Opportunity

Provide leadership and direction to assure compliance with all regulatory requirements while managing cost, collections, safety and organizational objectives.

You will report to the Sr. Director Quality Assurance.

The Role

1. Ensure center processes conform to Quality standards by collaborating and communicating with staff and provide assistance to resolve field quality issues with corrective action measures. Maintain frequent and open communications with corporate operations, regulatory and quality departments on issues that may potentially affect collected plasma safety, quality, identity, and purity. Review Quality metrics and reports for trends and opportunities for improvement, such as center self-inspections; provide feedback to foster a philosophy of continuous improvement.

2. In collaboration with Associate director of operations, assists Center Leadership in audit preparation. Reviews CAPA plans for suitability and utilize processes to administer operational compliance. Participate in audits as required. Manage audit outcomes-during and after the audit-escalating as appropriate as issues identified. For audit findings, assists center with response in a timely fashion to address the compliance concern for review. Represent company to Regulatory agencies and inspectors.

3. Responsible for ensuring Quality compliance is in place and performs as expected to manage CSL Plasma’s GxP regulated systems and processes. Conduct center visits to confirm QA, Operational and Safety performance.

4. Provide oversight of employee related issues.  This includes but is not limited to decisions for hiring, employee relations, corrective actions and salary structures.  Adhere to all HR policies and practices through fair and equitable treatment of all employees.  Communicate effectively with HR and operational counterpart to ensure HR compliance.  Develop center leadership team through hiring, training, coaching and effective succession planning.

5. Accountability for achieving quality metrics in area.

6. Directs Assistant manager of quality and Center Leadership through multifaceted investigations, risk assessments and problem-solving events ensuring timely remediation of complex situations.

Identify, review quality and safety risk as assigned centers and work with center leadership to develop appropriate actions.

7. Responsible for management and quality approval of deviations including system access. Directs quality oversight and guidance on systemic deviations that may negatively affect product, donor or employee safety.  Performs risk assessment, containment, corrective actions, root cause analysis and effectiveness in order to provide product impact determination. Management and oversight of GMP related complaints.

8. Determines Quality plans for the CSL plasma organization and leads large, complex project initiatives that may have both local and global impact.  Participates on operational projects and implementation of process changes.

9. Support facility maintenance to highest safety, compliance, and cleanliness standards.  Partner with corporate facilities to ensure center compliance at all times.

10. Routinely collaborates with Associate Director of Operations to ensure centers meet operational, quality and safety KPI metrics and data integrity investigations.  May include joint center visits. Conducts routine tier meetings with Associate Director of Operations.

11. Develop & maintain process to disseminate quality interpretation & strategies to operationalize relevant regulations, guidance’s & standards in collaboration with stakeholders. Maintain & deliver Quality development training and provide consistent technical guidance to operational leaders. Develop, deploy and deliver Quality information/ publications to appropriate Corporate and Center staff.

12. Support excellent customer service activities in centers.

13. Informs Regional Director of Quality of emergent situations capable of disrupting operations and develop strategies  through collaboration with operational leaders to maintain stable operations. Maintain frequent and open communications with corporate operations and quality departments on issues that may potentially affect collected plasma safety, quality, identity and purity. 

14. Other job-related duties as assigned.

Your skills and experience

Education

• Bachelor’s degree in biological science, management or other medically related field required.

• MBA and professional regulatory affairs certification preferred

• ASQ Quality Certification preferred.

Experience

• Minimum 4 years management experien