Who we are?
We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 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 320 employees.
JOB SUMMARY:
Responsible for ensuring Current Good Manufacturing Practices are followed during the Receipt, Sampling, Storage, Testing, Manufacturing, and Distribution of components, intermediates, and finished goods. Position is responsible for the management and oversight of the following functions:
- Product Release: Review and release or rejection of all raw materials, packaging components, intermediates, and finished goods.
- Deviation Management: Quality Assurance oversight of Deviation Management system.
- Technical Complaint Management: Investigation, documentation and approval of technical complaints and adverse events. (Adverse events at the request of Drug Safety)
- Annual Product Review Management: Annual Product Review document creation.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Safe, Effective Products (20%)
- 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. Review includes the determination that deviation investigations are sound, meet current regulatory requirements and ensure product is safe and effective.
- 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. Ensures audits run smoothly and demonstrates controls appropriately.
Effective, Efficient Quality System (20%)
- Provides leadership and management of the Complaint Handling Process. Ensures complaints are appropriately investigated in a timely manner and meet regulatory requirements. Ensures trends are identified and acted upon if required.
- Provides leadership and management of the Annual Product Review (APR) process. Ensures APRs are relevant, meet regulatory needs, and provide feedback to the organization regarding continuous improvement opportunities.
- 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. Challenges the way it has always been done.
- 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.
Skills & Performance of People Are Appropriate for Business Needs (20%)
- 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. Facilitates the implementation and acceptance of change within the workplace. Acts as a champion for change. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with changing activities.
- 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. Uses this information to drive improvements and/or prepare for changing requirements.
- Ensures an effective learning environment by coaching employees, orchestrating learning opportunities, and providing relevant, high-impact feedback.
Investigations Reach Sound Conclusions and CAPA's are Identified (20%)
- Provides leadership and management of the deviation system. Ensures deviations are thorough and in compliance with regulatory requirements.
- 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.
Quality Guidance & Advice (20%)
- 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.
People Leadership & Talent Management Responsibilities
- Provide direct leadership and oversight of assigned staff, including performance management, annual performance evaluations, ongoing coaching, mentoring, and goal setting.
- 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.
QUALIFICATIONS/EXPERIENCE:
- 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.
SPECIFIC SKILLS:
- 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.
PHYSICAL REQUIREMENTS/ENVIRONMENT:
- Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.
- Must be able to work on a computer for extended periods of time.
- Must wear safety glasses and other protective items as required.
- Sitting 75% of the day; standing or walking 25%.
