Manager, Quality Systems

SUMMARY:

The Manager, Quality Systems is an on-site, Mon-Fri role, responsible for developing, implementing, and maintaining quality systems including but not limited to:

Change Control Deviations / Investigations / OOS Corrective and Preventive Action (CAPA) Document Management and Control Record Management and Retention Training Management Product Quality Complaints Quality Metrics Management Review / Quality Review Board Internal Audit Program

Works with management and employees across the organization to ensure implementation of and compliance to an effective and compliant quality system to achieve business, operational, and quality goals.

The Manager, Quality Systems, is responsible for managing audits regulatory inspections and providing documentation support for regulatory submissions. As needed, will support QA Operations activities including participation as quality representative on project teams supporting products in development, and performing quality functions including, but not limited to, product release and stability oversight.

DUTIES AND RESPONSIBILITIES:

Serves as a leader for development, implementation, and continuous improvement of all quality systems.

Responsible for maintaining document management systems for creation, approval, maintenance, issuance, control, and storage of GxP documents, which may include liaising with third parties to secure required documentation and/or store GxP documentation. Documents include, but are not limited to:

Technical transfer and validation documentation Batch records and batch release documents and data Stability protocols, data, and reports GxP documentation associated with quality systems etc.

Assists in establishing and delivering training programs and continuing education programs in the areas of quality assurance with emphasis on ensuring that the employee base has a clear understanding of regulatory quality system processes and tools including GxP requirements. Assist other departments in defining training requirements and liaise to ensure successful implementation.

Responsible for coordination and preparation for Management Review Meetings. Responsible for collecting key quality and compliance metrics for presentation of monthly Quality updates and Management Review meetings. Responsible for preparing minutes, action plans, etc. and following up to ensure resolution of issues.

Responsible for setting up business tools and business processes to collect and capture Quality-related data to ensure reporting efficiency.

Manages deviation, investigation, and product quality complaint programs

Manages the change control and corrective and preventive action processes including leading teams, monitoring system performance, and reporting on progress.

Manages the Internal Audit program, including scheduling, conducting audits, supporting investigation of findings, and approving compiled responses.

Supports investigation and documentation of all product quality complaints. Works with Medical Affairs team who manages the relationship with contract pharmacovigilance provider.

Recommends change and process improvements to the organizational quality management systems to ensure sustained compliance and operational efficiencies.

Responsible for coordination and preparation for Quality Review Board Meetings. Responsible for preparing documents for discussion, attending, preparing minutes, and follow-up.

Serves as interface to third party organizations and regulatory agencies, particularly during third party audits.

Responsible for supporting audits and regulatory inspections and being part of the team that responds to findings. Responsible for managing audit/regulatory inspections. Responsible for follow-up and communication on actions committed as a result of audit/regulatory inspection.

Participates in educational programs related to pharmaceutical activities which have special emphasis in quality assurance and compliance with regulations and standards.

Based on changing regulatory requirements, assist and facilitate revising, improving, and developing programs, policies, and procedures to ensure sustained compliance of the quality system.

Manage internal and third-party investigation and deviation meetings. Communicate product quality issues to management and provide information when out of specification results, investigations, or other issues impact batch disposition or the status of marketed batches.

QUALIFICATIONS:

• Bachelor's Degree
• Minimum eight years experience in the pharmaceutical, medical device, vaccines, blood, or biologics industry
• Minimum 5 years experience in quality assurance with quality systems responsibilities
• Supervisory experience preferred

COMPETENCIES:

• Knowledge of regulated quality systems management including but not limited to: Auditing Document Control Training System Administration Customer Feedback Deviation and Complaint investigation Corrective and Preventive Action Change Control Handling Regulatory Inspections Management Review Knowledge and experience in GxPs and with regulatory/accreditation agencies Knowledge of process design/redesign, performance measurement systems, and audit procedures and protocols
• Strong organizational skills
• Strong computer skills
• Ability to handle multiple projects
• Ability to manage technical personnel and information
• Ability to work independently with little direction
• Technical Skills: Assesses own strengths and weaknesses Pursues training and development opportunities Strives to continuously build knowledge and skills Shares expertise with others
• Interpersonal Skills: Focuses on solving conflict, not blaming Maintains confidentiality Listens to others without interrupting Keeps emotions under control Remains open to others ideas and tries new things
• Oral Communication: Speaks clearly and persuasively in positive or negative situations Listens and gets clarification Responds well to questions Demonstrates group presentation skills Participates in meetings Ability to communicate clearly and concisely in a variety of environments (from one-on-one setting to large groups)
• Written Communication: Writes clearly and informatively Edits work for spelling and grammar Varies writing style to meet needs Presents numerical data effectively Able to read and interpret written information
• Teamwork: Balances team and individual responsibilities Exhibits objectivity and openness to others views Gives and welcomes feedback Contributes to building a positive team spirit Puts success of team above own interests Able to build morale and group commitments to goals and objectives Supports everyones efforts to succeed
• Visionary Leadership: Displays passion and optimism Inspires respect and trust Mobilizes others to fulfill the vision Provides vision and inspiration to peers and subordinates
• Change Management: Develops workable implementation plans Communicates changes effectively Builds commitment and overcomes resistance Prepares and supports those affected by change Monitors transition and evaluates results
• Quality Management: Looks for ways to improve and promote quality Demonstrates accuracy and thoroughness
• Business Acumen: Understands business implications of decisions Displays orientation to profitability Demonstrates knowledge of market and competition Aligns work with strategic goals
• Cost Consciousness: Works within approved budget Develops and implements cost-saving measures Contributes to profits and revenue Conserves organizational resources
• Ethics: Treats people with respect Keeps commitments Inspires the trust of others Works with integrity and ethically Upholds organizational values
• Organizational Support: Follows policies and procedures Completes administrative tasks correctly and on time Supports organizations goals and values Benefits organization through outside activities Supports affirmative action and respects diversity
• Strategic Thinking: Develops strategies to achieve organizational goals Understands organizations strengths & weaknesses Analyzes market and competition Identifies external threats and opportunities Adapts strategy to changing conditions
• Judgment: Displays willingness to make decisions Exhibits sound and accurate judgment Supports and explains reasoning for decisions Includes appropriate people in decision-making process Makes timely decisions
• Motivation: Sets and achieves challenging goals Demonstrates persistence and overcomes obstacles Measures self against standard of excellence Takes calculated risks to accomplish goals
• Planning/Organizing: Prioritizes and plans work activities Uses time efficiently Plans for additional resources Sets goals and objectives Organizes or schedules other people and their tasks Develops realistic action plans
• Professionalism: Approaches others in a tactful manner Reacts well under pressure Treats others with respect and consideration regardless of their status or position Accepts responsibility for own actions Follows through on commitments
• Quality: Demonstrates accuracy and thoroughness Looks for ways to improve and promote quality Applies feedback to improve performance Monitors own work to ensure quality
• Quantity: Meets productivity standards Completes work in timely manner Strives to increase productivity Works quickly
• Adaptability: Adapts to changes in the work environment Manages competing demands Changes approach or method to best fit the situation Able to deal with frequent change, delays, or unexpected events
• Attendance/Punctuality: Is consistently at work and on time Ensures work responsibilities are covered when absent Arrives at meetings and appointments on time
• Dependability: Follows instructions, responds to management direction Takes responsibility for own actions Keeps commitments Commits to long hours of work when necessary to reach goals Completes tasks on time or notifies appropriate person with an alternate plan
• Initiative: Volunteers readily Undertakes self-development activities Seeks increased responsibilities Takes independent actions and calculated risks Looks for and takes advantage of opportunities Asks for and offers help when needed

PHYSICAL DEMANDS:

• Occasionally required to walk
• Constantly required to sit
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: Close vision Color vision Ability to adjust or focus
• Some travel is required including overnight stays, estimated <10%

WORK ENVIRONMENT:

• The noise level in the work environment usually is quiet