Manager, Manufacturing Quality Assurance and Environmental Monitoring (2nd Shift)

USE YOUR POWER FOR PURPOSE

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those who rely on our products.

WHAT YOU WILL ACHIEVE

In this role, you will:

• Lead and manage people, technology, and financial resources within the department, ensuring alignment with short-term goals

• Actively share knowledge and provide technical guidance and oversight to team members, fostering a collaborative environment

• Identify and implement potential improvements in processes or products, taking calculated risks to develop innovative ideas

• Manage the performance of direct reports through goal setting, coaching, and ongoing assessment, recognizing the need for development and creating development plans

• Communicate effectively by soliciting input, explaining complex concepts, and persuading others to adopt a point of view, while sharing own perspectives and rationale

• Evaluate and review clinical and commercial batches of drugs, ensuring compliance with established specifications through rigorous sampling and statistical process control procedures

• Approve investigations and change control activities, maintaining compliance with configuration management policies and overseeing site prioritization and management escalation meetings

• Develop and oversee inspection preparation plans for key Good Manufacturing Practices (cGMP) elements, providing Quality Assurance expertise and guidance to colleagues and external parties

• Prepare departmental budgets, control costs, interface with Regulatory Agencies during audits, and manage audit report distribution to ensure timely delivery of critical information and regulatory commitments

HERE IS WHAT YOU NEED (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience 

• Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry.

• Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced.

• Strong collaboration, relationship management, and interpersonal skills.

• Strong people management experience.

• Excellent written and oral communication skills.

• Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent.

BONUS POINTS IF YOU HAVE (Preferred Requirements)

• A solid understanding of device and combination product industry regulations.

• Strong analytical and problem-solving skills.

• Ability to work independently and make decisions.

• Excellent organizational and time management skills.

• Experience in interfacing with regulatory agencies during audits.

• Ability to drive continuous improvement initiatives.

• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

PHYSICAL/MENTAL REQUIREMENTS

• Must not have a Penicillin allergy.

• The position will require lifting, bending, and standing for periods of time, use of ladders and working within controlled environments.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Non- Standard work schedule at times maybe required to support product release, including weekend, second shift, night shift work / call for process decisions.

• Minimal travel for training/seminars.

• Role is for an afternoon shift position (2nd shift).

Work Location Assignment: Onsite

The annual base salary for this position ranges from $106 000,00 to $176 600,00. In addition