CSL Plasma Associate Director Operations & Quality (New Centers) in Boca Raton, Florida
Home office position with extensive travel.
Provides leadership and direction to assure compliance with all regulatory requirements while achieving cost, collections, safety and organizational objectives for their assigned centers. Act as Quality resource to center compliance staff to ensure center business processes are compliant with FDA, GHA, OSHA, cGMP and other regulatory authorities ensuring the purity and efficacy of the plasma. Demonstrate company values to ensure success of the entire organization.
1 Responsible for quality compliance of each center in the region. 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 Develops processes to meet established individual center production goals by maximizing efficiencies, customer service levels and minimizing investment, monitor net yields, and implement improvement plans, when required.
3 Develop and implement effective processes to manage cost per liter. Responsible for obtaining HPD, labor cost, yield efficiencies, turnover rate and FT/PT ratio as well as overall cost.
4 Assists Center Management 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.
5 Identify, review quality and safety risk as assigned centers and work with center leadership to develop appropriate actions. Visit centers to confirm QA, Operational and Safety performance.
6 Monitor all marketing, advertising, applicant conversion rates and donor retention to ensure centers are executing programs for desired results and make recommendations as needed.
7 Provide oversight of employee related issues. This includes but is not limited to decisions for hiring, firing, corrective actions and salary structures. Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance. Develop center leadership team through hiring, training, coaching and effective succession planning.
8 Ensure excellent customer service in centers. Provides a good customer model service to employees, communicate openly with customers, ensure efficient donor flow and processing times and effectively resolve complaints or concerns in a timely manner.
9 Support facility maintenance to highest safety, compliance and cleanliness standards. Partner with corporate facilities to ensure center compliance at all times.
10 Perform other duties, as assigned, to support business needs.
• Bachelor’s Degree in business administration or biological sciences program or equivalent combination of education, training and experience required
• Minimum 5 years management experience, including managing employees required
• Experience managing multi-site locations preferred
• Progressively more responsible positions in a complex organization and experience working in a regulated environment preferred
• 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, training, written and verbal communication and interpersonal and presentation skills to drive results
• Understand regulatory standards, various local, state and federal laws that apply to the business and where to find information on standards and interpretations
• Experience planning, organizing, securing and managing project resources preferred
• Proficient at providing assistance and directing managers to identify and resolve problems preferred
• Proven skills in budgeting and financial management
• Leading, developing and managing remote employees
• Intermediate to strong working knowledge of Microsoft Office products
• Maintain company technical training certification, current professional licensure or certifications, knowledge of ever-changing and complex government and industry regulations and ability to monitor compliance remotely with these regulations
• Monitor and manage entire financial responsibility in a Region
• Proficient in English
• Ability to interact with regulatory auditors as necessary
(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
• Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens
• Overnight travel required up to 75% of the time without lengthy lead-time
• Stand and work up to 100% of the time, working sitting at desk 15% of the time performing Remote Critical Process Review and attend Regional and National Managers meetings 10% of time
• Occasionally lift and carry up to 25 lbs.
• Frequently required to reach, bend, kneel and have high level of manual dexterity
• Manage a center in the absence of center management
• Assure employee, customer and product safety for region
• Required to wear Personal Protective Equipment while performing specific tasks or in certain areas
• Fast paced environment with frequent interruptions
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.
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