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About the Role

Reporting to the Quality Director, this role is responsible for ensuring Current Good Manufacturing Practices are followed during the Receipt, Sampling, Storage, Testing, Manufacturing, and Distribution of components, intermediates, and finished goods. The position manages and oversees Product Release, Deviation Management, Technical Complaint Management, and Annual Product Review Management.

Responsibilities

• Provides management and direction to the Material Release system to ensure products and materials are thoroughly reviewed and meet all regulatory requirements prior to release or rejection.
• Manage product recall process.
• Leads the team that provides Quality Assurance review and approval of deviations.
• Ensures CAPA’s address root cause and reduce recurrence rates.
• Ensures management is notified of product and process risks.
• Provides leadership during customer and regulatory audits.
• Provides leadership and management of the Complaint Handling Process.
• Provides leadership and management of the Annual Product Review (APR) process.
• Ensures the development, documentation and implementation of standardized processes for key business functions.
• Develops quantitative techniques to monitor process performance.
• Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change control documentation is implemented.
• Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness.
• Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance.
• Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage.
• Ensures stakeholders are appropriately trained on the process and any process changes.
• Ensures self and staff understand the organization’s vision, values, goals and strategies and their relationship to their daily work.
• Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly.
• Helps others to successfully manage organizational change.
• Understands HR policies and practices and uses them to manage employees.
• Ensuring money, technology, and staff are allocated to achieve optimal results.
• Ensures self-esteem and staff keep up to date on technical knowledge and developments that impact roles.
• Ensures an effective learning environment by coaching employees, orchestrating learning opportunities, and providing relevant, high-impact feedback.
• Provides leadership and management of the deviation system.
• Works with individuals performing investigations to ensure the process is handled with the appropriate level of detail.
• Works with the appropriate discipline to identify corrective/preventative measures necessary for each observation made for improvement and to align processes to consistently manufacture quality products.
• Reviews and approves investigation reports to ensure they contain the appropriate level of detail and appropriate CAPA’s are identified.
• Works with the customer to obtain approval.
• Provides QA consultation to project teams and the organization in general.
• Provides guidance in the development of and review and approval of CAPA associated with Deviations, Product Complaints, Investigations, Audits, and Inspections.
• Ensures deviations, change controls, etc. are technically sound from a quality standpoint.
• Interfaces with customers and suppliers when necessary to resolve specific quality problems.
• Provide direct leadership and oversight of assigned staff, including performance management, annual performance evaluations, ongoing coaching, mentoring, and goal setting.
• Conduct regular managerial touchpoints with supervisors and team members to reinforce expectations, increase engagement, and support individual and team development.
• Partner with Human Resources to support workforce planning, staffing needs, interviewing, and selection of qualified candidates.
• Actively participate in succession planning and organizational development initiatives, identifying high-potential talent and development opportunities within the manufacturing organization.
• Support onboarding, training, and ongoing development to ensure employees are equipped to meet operational, quality, and compliance expectations.
• Demonstrate flexibility and responsiveness to meet evolving business needs and HR-driven initiatives, including staffing adjustments, talent reviews, engagement efforts, and change management activities.
• Foster a culture of accountability, inclusion, engagement, and continuous improvement through consistent leadership presence and communication.

Requirements

• Bachelor’s Degree (master’s preferred) in Biology, Chemistry, Pharmacy or related field.
• MBA and quality certifications a plus.
• Minimum 8-10 years of experience in Pharmaceutical FDA regulated environment.
• CMO Preferred.
• Experience in Quality Assurance Management position in manufacturing, facility operation, laboratory compliance and quality systems.
• Previous supervisory experience required.
• Experience interacting with regulatory authorities.
• Ability to influence individuals throughout the organization.
• Comprehensive understanding of current regulatory requirements and ability to interpret them.
• Experience in audits and regulatory inspections (FDA & others).
• Ability to analyze complex situations and processes.
• Advanced Track Wise skills.
• Basic Outlook skills.
• Basic Microsoft Word skills.
• Intermediate Excel skills.
• Intermediate PowerPoint skills.
• Must be able to work on a computer for extended periods of time.
• Must wear safety glasses and other protective items as required.

Skills

• Track Wise
• Outlook
• Microsoft Word
• Excel
• PowerPoint

Location

• Rochester, NY

Work Type

• Full-time

Experience Level

• 8-10 years
• Management
• Supervisory

Education Level

• Bachelor's Degree
• Master's Degree

Salary/Compensations

• 115,000.00 - 127,000.00 USD

Benefits

• 100% employer-paid medical premiums
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses and merit increase eligibility

About the Company

• As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible.
• As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees.
• Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.
• We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
• Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.
• We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
• We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
• We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
• Join us and make a difference!

Equal Opportunity

• Unither is an Equal Opportunity Employer.
• We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.