Senior Manager, Operations & Production Maintenance

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 280 employees.

Your role

Reporting to the General Manager, North America,

Ensure Customer Satisfaction

Deliver the ordered quantities within the requested delivery dates of all customers to meet or overachieve our contractual commitments.

Measure and evaluate his team regarding to the standard production leadtime and the Documentation Right-First-Time expectation

Ensure the quality level of the products is confirmed to cGMP Standards and negotiated customers’ requirements

Successfully pass all customers and authorities inspections and audits repetitively

Execute the production schedule provided by the Supply Chain department and organize all the means under his responsibility, including shifts and people availability to guarantee a level of adhesion of at least 95%.

Collaborate closely with the Product Development department and organize all the necessary means (resources, line, equipment…) to support the production of development products on-time while maintaining a commercial production schedule to satisfy the other customers.

Ensure the efficiency, productivity and profitability of all the areas under his/her responsibility

Reduce non-Quality and guarantees Achievement of the contractual products Right-First-Time

Effective & Efficient Operations

Ensure the efficiency, productivity and profitability of all the areas under his/her responsibility

Create, challenge and implement standard operating procedures for all production operations. Develops quantitative techniques to track and monitor process performance.

Ensure development of operational systems and processes to optimize performance, reduce cycle times, production costs, and drive OEE improvements. (Lean Manufacturing).

Apply existing SOPs and Technical procedures while evaluating their effectiveness, identifies changes that would enhance the process, propose them and implement them once approved by Quality.

Ensure stakeholders are appropriately and regularly trained and qualified to empower employees and increase accountability.

Manage and arbitrate operations, production maintenance to continuously use efficiently all the production lines, increase OEE, reduce downtime and support the customer demand.

Ensure compliance with the productivity performance of the different lines

Develop, using training, knowledge transfer and empowerment, the appropriate autonomy of the operators (ex: Changeover, Sampling, Testing, Maintenance Level 1…) to drive continuous improvement

Define, implement and periodically review with the Production Maintenance, Engineering and Operations the appropriate Preventive and Curative Maintenance plan

Define and deploy a Continuous Improvement approach and process with reporting (based on data and analytics) to support the action plans and demonstrate the results.

Develop, maintain and communicate to appropriate levels, KPI allowing for the making and execution of SMART business decisions for continuous improvement.

Builds, Tracks and Manages its operating and investment budget according to the site Master Plan once approved

Propose productivity ideas and improvement plans while developing his budget

Identify and actively work on reducing yield losses in general and especially high-value price active ingredients and components.

Culture of GMP Compliance & Safety

Manage processes according to the cGMP and the Site Quality Management System

Follow all cGMP and HSSE rules and regulations, leads by example, and holds others to the same.

Accept accountability for compliance and personal safety and ensures that the employees under his/her supervision are complying with all HSSE and cGMP requirements.

Support and assure compliance to cGMP, compliance, safety regulations, policies, procedures to obtain no critical observations during audits and inspections.

Utilize understanding of regulatory environment and industry trends to identify ways to improve quality and compliance.

Manage all the changes that may have a regulatory impact, on the quality of products manufactured and on the control of critical parameters

In collaboration with Validation, control the parameters of the critical equipment and ensure their traceability on a continuous basis.

Ensure complete traceability of maintenance intervention and information/ Ensure documentation compliance and traceability of adjustment or modification on equipment

Coordinate and ensures the closure, within time, of the quality investigations following a malfunction of equipment and / or during production

Ensure the application of 5S on the floor and the compliance post audits

Strictly respect the CAPA deadlines for regulatory and customer audits as approved with Quality

Resolve safety problems as required, investigate accidents using root cause analysis and fishbones and resolve at root cause level, support and / or lead safety training and related safety requirements.

Participate in safety inspections as required.

Comply with and assists in enforcing all site security requirements.

Assist in ensuring that site activities do not create a negative impact on the environment.

Production Capability Meets Current and Future Customer Requirements

Translate the company strategy into multi-year operational strategies that anticipates the evolution and future of the business

Represent Operations in the S&OP and Production Plan process to ensure production plans and capacity meet current and future demand, including non-commercial activities that could impact the production schedule.

Propose planning adjustment as necessary to be more coherent with the equipment performance

Target business activities against strategic priorities to achieve maximum quality, cost and customer service. Drives assessment and upgrading of equipment in pursuit of continuous improvement.

Maintain and foster communication between Quality, Engineering, Product Development, Supply Chain and the Operations group to ensure that orders are filled, and that product meets customer requirements in terms of quality, quantity, consistency, and timeliness.

Participate in new business technical feasibility assessments by participating in the preparation of new business or customer proposals and facilitate successful new product launches by leading the production strategy for onboarding new projects/products.

Provide appropriate support to the Engineering, Validation, Qualification and Metrology departments during the development and implementation of new equipment on site but also on during routine activities on existing equipment by ensuring appropriate operations and maintenance resources are available in a timely manner.

Skills & Performance of People Are Appropriate for Business Needs

Ensures self and staff understand, unite and align with the company’s values and apply them in their daily work.

Ensures the adequacy of trainings/qualification of his team based on their roles and missions

Développer les compétences et l'autonomie de l'équipe

Develop team skills and autonomy

Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals during performance reviews; providing clear, thorough, timely feedback; and addressing and documenting performance problems and issues promptly.

Acts as a champion for change. Facilitates the implementation and acceptance of change within the workplace.

Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities.

Understands and follows HR policies and practices and uses them to manage employees.

Uses information and data to drive improvements and/or prepare for changing requirements.

Analyzes the skills and capabilities of his areas of responsibilities; identifies future workforce requirements, needed training; and close any gaps in collaboration with HR Department.

Develops an organizational structure that supports the retention and development of staff to deliver a high level of performance, as well as offers career development for high performers/ high potentials.

Diagnoses whether assigned functional areas are performing at full potential and ensures communication cascades down through the organization to engage employees and define priorities and goals as needed

KNOWLEDGE SKILLS & ABILITIES:

Must be fluent in the country language

Knowledge of aseptic manufacturing and filling

Knowledge of manufacturing and packaging in a pharmaceutical operation

Knowledge of production planning and S&OP process

Knowledge of Lean and Operational Excellence applications in the pharma industry

Knowledge of cGMP and FDA and International regulations

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 55% of the day; standing or walking 45%.

Your profile

Bachelor’s Degree in Chemistry, Biology, Pharmacy, Engineering or related field required; Masters preferred

Minimum 15-year experience in FDA or other regulatory agency environment.

A minimum of 10 years in a leadership/management position in Operations

A minimum of 3 years in a Supply Chain management role

Must be knowledgeable in regulatory and technical requirements of the pharmaceutical industry, have interacted directly with regulatory agencies, and have a strong management background.

Experience in audits and regulatory inspection including PAI.

Experience in aseptic manufacturing, filling, and packaging, facility operation, and quality systems

Compensation range

150,000.00 - 180,000.00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Learn more about us:

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!