Quality Systems, Manager

1. JOB SUMMARY

The Manager, Quality Systems is responsible for management and oversight of personnel and quality systems by networking with internal and external stakeholders to positively influence the compliance health of the company. This is a key role which contributes to the continuous improvement of quality and compliance at the Rockville site.

2. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Serve as the Subject matter Expert on site Quality Systems and provide guidance and interpretation to internal stakeholders.
• Manage the generation, execution and technical review of data and documentation, ensuring that they are maintained in compliance with FDA regulations, global regulations, and Emergent internal directives.
• Lead preparations for internal, external, and other regulatory agency inspections (FDA, EMU, etc.). Manage resolution for both audit and inspection findings.
• Oversee and manage site’s Quality Risk Management Systems to ensure proper follow up and closure of identified risks. Collaborate with other impacted Emergent’s sites and functions to ensure identified gaps from emerging regulations are addressed.
• Review and approve compliance documentation such as procedures, contracts, audit reports and quality agreements.
• Lead and manage the CAPAs, Deviations, Change Controls, Audits and Supplier Quality Management program. Responsible for timely completion of compliance, change controls and CAPA commitments.
• Develop and implement procedures for compliant and effective Quality Management Systems. Streamline processes and effectively utilize tools and resources to improve site compliance.
• Establish, track and present Quality Metrics to support Quality Management Review.
• Participate as Quality Assurance representative on various project teams with impact to compliance and/or the Quality Systems.
• Support the Quality team during deviation/formal investigations, including participating in root cause analysis activities, document review and verification, determination of corrective/preventive action and assessment of product impact.
• Maintain current knowledge of industry standards and regulatory requirements.
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Management

• All functions associated with recruitment and hiring process for department
• Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
• Mentor, train and develop team members.
• Define resource requirements, plans, and prioritize resources.
• Conduct personnel interviews, performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to group
• Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as applicable
• Mentor, coach, challenge, and develop team members while serving as a role model of Emergent’s core values
• Ensure the team effectively collaborates with key internal and external stakeholders, in accordance with our corporate values and practices

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

     Education:

• BA/BS degree, preferably in a life science related discipline, or equivalent work experience.

Experience:

• Minimum of 6 years of experience working in an FDA regulated industry including participation in agency inspections.
• Highly desirable to have minimum of 4 years of management experience.
• Demonstrated experience leading a staff through mentoring and coaching in support of business needs, evaluating performance and proactive handling of employee relations.
• Previous experience working with FDA and participating in regulatory agency inspections.
• Previous experience in management of Quality Systems. Previous experience operating within Quality Systems such as: Deviation, CAPA, and Change Control.

Knowledge:

• Must possess strong cGMP knowledge across Compliance functions.
• Must have competence of cGMPs, 21CFR, and up to date knowledge of regulatory guidance and expectations.
• In-depth working knowledge of Veeva Document System and SAP preferred.

Skills:

• Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
• Must have SOP, investigation, change control/corrective action, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents.
• Must have excellent verbal and written communication skills and the ability to successfully manage without authority in a cross-functional matrixed environment.

Abilities:

• Demonstrated capabilities (e.g., able to translate strategy to action, Effective verbal and/or written communicate at all levels of organization, work effectively in ambiguous situations, ability to multi-task, proven track record of increasing customer base)
• Must be able to critically evaluate data summaries and conclusions.
• Must be able to prepare reports for internal metrics and technical content.
• Ability to exercise judgment within defined practices and policies by selecting methods and techniques for obtaining solutions including strategic CAPA.
• Ability to work in a team environment as the quality representative with both internal and external customers.
• Must have strong attention to detail.