Responsibilities:

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.

JOB SPECIFICATIONS

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 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. May be required to lead teams without the benefit of a direct reporting relationship

• Establish solid working relationships to interface with and support senior management, third parties and other positions and circumstances within the organization

• Excellent customer service orientation with flexibility and adaptability to respond quickly to changes as required by the business operations

• Maintain a professional demeanor and handle confidential information with discretion

• Computer literate with proficiency in office applications and use of electronic quality and operational systems

Additional Comments

• 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

Working Conditions

(physical & mental requirements)

• Ability to make decisions which have significant impact on the department’s creditability, operations, and services

• Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations

• Stand and walk up to 100% of time, work sitting at desk 15% of time performing Remote Critical Process review and attend Regional and National Managers meetings 10% of the time

• Frequently exposed to hazardous chemicals, extreme temperatures and blood borne pathogens

• Overnight travel required up to 75% of the time without lengthy lead-time

• Frequently required to reach, bend, kneel and have high level of manual dexterity

• Required to wear Personal Protective Equipment while performing specific tasks or in certain areas

• Assure employee, customer, and product safety for CSL Plasma

• Ability to lift or carry up to 25 lbs.

• Fast paced environment with frequent interruptions

• Collaborate with operations to ensure adequate coverage in the absence of Quality leadership