Quality Compliance Director

Quality Compliance Director

Requirements

• Bachelor’s degree (BA/BS) with fifteen (15) years applied professional work experience in one of the following pharmaceutical work areas: quality assurance, compliance, manufacturing operations, technical operations; OR Master’s degree (MA/MS) with ten (10) years applied professional work experience in one of the following pharmaceutical work areas: quality assurance, compliance, manufacturing operations, technical operations.
• Applicable experience, strong understanding and knowledge of relevant quality systems expectations in the biotechnology or vaccine industry.
• Expert knowledge of cGMP relevant to the biotechnology or vaccine industry including knowledge of the local and international GMP regulations.
• In-depth knowledge of regulatory requirements and guidelines (e.g. 21 CFR part 11)
• Expert knowledge with audit or inspection management.
• Proven success in delivering compliance initiatives and organizational design/ establishment.
• Exceptional analytical and problem-solving skills, with the ability to distill complex data into actionable insights and recommendations.
• Ability to work independently while fostering collaboration in team settings and matrix organizations to achieve common goals.
• Highly skilled in listening to diverse perspectives, developing impactful solutions, and advocating for effective positions through influence.
• Strong working knowledge of Quality Management Systems, and associated business processes.
• Excellent communication, leadership, technical writing and problem-solving skills.
• Very skilled at organizing complex topics, strong project management skills, able to handle multiple tasks concurrently.
• Adapts to rapidly changing business needs, fostering a flexible and responsive approach to challenges.
• Ability to cultivate positive, transparent, and productive relationships across various stakeholders.
• A team player with high initiative, demonstrated planning skills, proven performance in problem-solving, team building and staff development.
• Fosters positive, transparent and productive relationships.
• Proven history of challenging the status quo of business standards and processes with the ability to propose solutions.
• Experience in working with cross functional teams as well as good leadership skills in a matrix organization.
• Proven history of developing strategic plans and implementing on time.
• Ability to be decisive and influence management with demonstrated leadership skills and management of large teams.
• Experience in managing cross-functional initiatives or programs.
• Understanding and experience in various business methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.)

Responsibilities

• Develop and implement comprehensive compliance program for the site to ensure Permanent Inspection Readiness (PIR), which includes leading the site audit program and inspection readiness team.
• Track and Interpret changes in regulations, industry standards and ensure proactive awareness and PIR at the site.
• Champion engrained quality culture across the manufacturing site by enhancing learning and awareness of quality systems.
• Conduct regular compliance risk assessments, identify potential risks and develop strategies to mitigate the risks. Identify and address compliance issues, develop corrective action plans and implement improvements to compliance programs.
• Coach the site on quality risks to develop near and long term strategies with all operational related risks identified and escalation and mitigation of risks in a timely manner.
• Act as a liaison and/or SME to present operational compliance to Health Authorities and regulatory agencies on relevant topics.
• Lead a team of professionals who serve as contact for regulatory agencies during inspections, responding to inspectional or regulatory agency inquiries, providing information and addressing compliance concerns.
• Serve as lead for the team coordinating Health Authority reporting, Market action events, and complaint process management for the site.
• Health Authoring Reporting, including but not limited to BPDRs, DPRs, and FARs | Assesses events such as complaints and deviations and determines the need to report the event | Works with responsible teams to author and submit the required health authority notification and any follow-up action.
• Lead a team of site internal auditors to ensure PIR and monitor ongoing compliance activities.
• Provide training and guidance to employees on compliance related matters, ensuring a robust PIR and auditing program at the site.
• Provide expertise in developing strategies for inspection readiness including working with Regulatory with relevant submissions for new product launches.
• Skills in engaging and collaborating with various functional teams (e.g., Operations, Technology, Automation, Regulatory, Research).
• Act as a partner to applicable network teams and communities of practice associated with compliance, facility fitness, inspection readiness, data integrity and other programs as applicable.
• Partner across Quality and other key stakeholders to ensure the monitoring of third party supplier’s compliance with requirements of cGMPs and applicable regulations.
• Ability to build relationships and work effectively in a team-oriented environment.
• Engage and drive continuous improvement initiatives across the site to drive simplification and standardization.

Preferred Qualifications

• People Management