Quality Lead

The Site Quality Operations Leader partners with the Site Operations Leader and is mutually accountable for quality performance at the site, driving regulatory excellence, ensuring a supply of quality products which are compliant with regulatory requirements and meeting the needs of both internal and external customers. The Site Quality Operations Leader is accountable for the design, implementation and execution of an effective Quality Management System that ensures product quality, regulatory compliance, for the site. The scope of this role also includes quality budget and resources planning, performance metrics/ dashboard, strategic planning, establishing a quality policy and objectives. The Site Quality Operations Leader is accountable for providing leadership to the site in ensuring compliance of all materials, packaging components, and in-process and final commercial products with established specifications, compliance with regulations and other applicable standards and directives.

Role

• Leadership: The Site Quality Operations Leader is considered the Site Quality Authority and will lead the site’s Quality organization. The SQOL manages the Quality Management System and is accountable for its effectiveness and maintenance, including any periodic certifications. Serves as the chairperson of the Site Quality Review Team (SQRT).
• Relationships: Achieves compliance and business results through Partnerships between Quality and Operations and other site/cross site functions. Is an active member of the Site Leadership Team.
• High Performance Culture: Creates a high achieving Quality & Compliance team with goals and values aligned with other team members and operations, collaborative team environment, and high-performance culture within the site Quality and Compliance organization. Drive decision making and knowledge to level at which the work is happening.
• Talent Management Focus: Oversees the conduct of Talent Management programs to develop future leaders and the creation of robust succession plans for the Site Quality and Compliance Organization. Directs, oversees and participates in the recruitment, selection, promotion, termination and performance management of site personnel in leadership and critical roles. Leads the following activities: Job Description, Training curricula, Development plans, Performance appraisals and Performance coaching.
• Assures the organization to ensure it has the appropriate scientific, regulatory and technical product expertise to assure sound decision making and business continuity.
• Issue Resolution: Ensures the creation and implementation of clear and timely action plans for issue resolution with appropriate escalation, communication, and closure.
• Regulatory Excellence: Ensures sustainable regulatory excellence through systems, science, people, and continuous process improvements. Ensures a favorable site regulatory profile through constant inspection readiness programs; ensures successful inspections. Creates effective relationships with regulatory agencies to create trust and credibility. Prepares the site for changes to regulations.
• Quality Systems: Ensures and effective and compliant site Quality Management Systems are in place. Develop new systems as new products/processes are implemented.
• Quality Planning: Ensures the creation and execution of a sound Quality Policy and Quality Objectives that are consistent with both site and Global Quality Operations objectives.
• Industry Standards: Drives understanding of appropriate industry standards across the site organization. Follows actively and anticipates impact of emerging regulations on site operations and prepares site for implementation and change, as appropriate.
• Corporate Policy: Drive compliance with applicable PQS standards and other appropriate corporate guidance documents.
• Product Disposition: Ensures independent and timely product disposition using validated processes, analytical methods, and documented decision making processes.
• Technology and Science: Holds self and others accountable for making decisions, solving problems, or driving improvements through a sound understanding of the technology and science of the products and processes.
• Operational Excellence: Drives innovation and continuous improvement through Operational Excellence in all Q&C activities and supports OE throughout the site.

Professional Profile

• BS / BA Degree, preferably in relevant disciplines (Business, Engineering, Science, Management or related field)
• A Master’s Degree in relevant disciplines is desirable.
• At least 10 years work experience in the pharmaceutical or medical device Industry preferably within different functions within Operations, Quality & Compliance, and/or Research and Development with 3 or more years of supervisory experience
• Knowledge of Good Manufacturing Practices, Corporate Quality Standards, Project Management, salary administration, recruiting, training and developing staff, and cost and budget management.
• Strong communication, negotiation and leadership skills required
• A highly motivated change agent who can work collaboratively and energize others to drive change
• Passionate about people, development and motivation and have the ability to manage multiple priorities and delegate appropriately in a fast paced, regulated work environment.
• Ownership of a comprehensive Quality Management System including the outsourcing of components of a \ Quality Management System.
• Quality Head and Management Representative of a Medical Device Legal Manufacturer.
• Making sound and effective decisions under pressure
• Managing a Quality/Compliance function with product release responsibilities
• Work experience in functions outside Quality/Compliance, e.g. Technology, Validation.
• Operations, Regulatory Working with other manufacturing and R&D sites to understand a broader perspective.
• Hosting of regulatory inspections including interactions with regulatory representatives and responding to observations. Working with multicultural, cross-functional work teams. Advancing a quality culture in a manufacturing environment
• Evaluating and continuously improving site Quality Systems
• Experience with selecting and developing people and managing performance of individuals and groups.
• Project management
• Knowledge of ISO 13485 and CFR 820, and other related Medical Device standards and requirements.
• Manufacturing Environment and processes and interdepartmental linkages.
• Experience with Quality Planning
• Advancing a culture of quality, Global regulatory environment and processes
• Quality Assurance and Quality Control, Manufacturing Science and Technology
• Finance planning and budgeting.

TECHNICAL SKILLS REQUIREMENTS

• Awareness and understanding of Pharmaceutical industry including key facets of the regulatory processes, role of the EMEA, FDA and other relevant regulatory bodies, and basic overview of typical manufacturing processes and cycle times.
• Possesses ability to collaborate widely across the local site, with affiliates, and regional/ global teams. Must be able to build strong relationships, coach and influence peers and key stakeholders. Leads for change and embraces a continuous improvement philosophy and approach to work.
• Influencing Others/ Change Leadership
• Excellent communication skills at all levels appropriate to the needs of the audience. Maintains a clear focus on the needs of the customer and is a champion of customer service. Develops strong and enduring relationships with key stakeholders.
• Communicating with impact/ Customer Orientation/ Developing Strategic Relationships
• Drives through the execution of the project plans/ key milestones with a close attention to the details and quality of output. Ensures that the needs of the business are reflected in all key decisions and project plans.
• Execution/ Understands the Business
• Demonstrates an ability to respond quickly and thoughtfully to changing priorities and demands placed upon the business. Maintains clear focus on the goals and deliverables of the strategy and relevant project plans.
• Adaptability, Driving for Result

Angelini Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity and/or expression, sexual orientation, national origin, genetics, disability, age or veteran status.

About Us: Angelini is a medium size private international group, a leader in health and wellness in the field of pharmaceutical and consumer products. Born in Italy in the early twentieth century, the Angelini group has offices in 17 countries and worldwide distribution of products. Angelini Pharma Inc. is the US business unit, headquartered in Atlanta, GA. In 2020 Angelini Pharma Inc. acquired the ThermaCare production facility in Albany, GA.