Quality Control Manager - Unither Pharmaceuticals : Job Details

Quality Control Manager

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 Quality Director,

The Quality Control Manager oversees all activities relevant to the quality control in a pharmaceutical Contract Development and Manufacturing Organization, from the incoming inspection of the materials, through the testing (microbiology and chemistry) of the fluids, raw materials, bulks and finished products, to the stability testing and certifying the products on the market meet with the specifications through the expiration date.

That includes the resources management (employees, instruments, external companies, standards & regulations, budget and costs), and the maintenance and/or calibration of the equipment and software used in the laboratories.

As a member of the quality team and GMP organization, the Quality Control Manager must meet the regulations in place for sterile and non-sterile products and ensure that the Quality Control department is able to propose continuous improvement.

This position interacts with manager and director levels of management in all departments in developing solutions and providing timely and accurate communication. As a Quality Control Manager, frequent interactions will occur with our customers including documentation approvals, deviations, change controls and various meetings and business reviews. The Quality Control Manager will serve as the main QC contact for customers regarding deviations, change controls, audits, and any other quality control concerns.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Employee Development & Training

Define the staffing and training needs of the Quality Control department to carry out the industrial and commercial plan

In collaboration with managers, ensure the implementation of the annual training plan

Ensure the adequacy of the team's qualification in relation to the missions

Develop the team's skills and autonomy

Oversee staff training on all lab equipment and ensure all training for each device is up to date

Define priorities for action, in relation to means, resources and deadlines

Conduct annual performance evaluations and assess the development and performance of your team

Formalize and monitor quantifiable objectives for the analytical and microbiology control activities.

Cost Management

Establish relevant indicators and control ranges in a budget process to be validated by management

Create quarterly activity reports and justify any deviations observed in relation to the budgetary assumptions

Anticipate and justify all resources needed for quality department (employees, equipment, instruments, software)

Testing (Chemistry & Microbiology)

Deliver certificates of analysis (raw materials, packaging components, finished products) to the customer quality department within standard deadlines

Evaluate the technical and document implementation of any new analysis method implemented and anticipate the commercial launch of development projects

Ensure all methods and specifications are updated in the LIMS

As a back-up to team leaders, accept or reject raw materials and packaging components within standard deadlines

Collaborate with logistics and production during Planning Meetings

Prioritize analysis according to the production master plan

Optimize your analysis by anticipating reception and production schedules

Control the flow and management of analytical samples

Oversee the monthly verification of reagent and standards expirations

Be the analytical expert by mastering the different analytical and control methods and by supervising the investigations

Carry out stability studies for which the site is responsible

Specifically, for Media Fill tests, oversee staff training, readings, sterility checks, reconciliation.

Ensure the application of procedures according to the standards described (FDA Guidance, GMP, etc.) and carry out sterility identifications and tests on time

Equipment & Instrument Management

Monitor the laboratory's equipment (status and validity limits) in collaboration with equipment experts

Plan equipment checks according to the VMP using dashboards

Ensure the completion of the qualifications (initial and annual) of the equipment

Maintain available equipment both in-house/outside sources

Define specifications and comparative files justifying the orientations

Create SOPs on Control Laboratory devices

Define all access management to systems, and software

Quality Requirements & Improvements

Ensure the drafting of investigations in the event of Deviations (OOS, OOT, deviations) in Compliance with the requirements of Quality Assurance and health authorities

Write expert and validation reports in the analytical field

Perform internal audits and participate in external audits for analytical subcontractors

Master the laboratory's documentary system by distributing procedures, keeping logbooks, and recording documents

Develop and manage processes to ensure compliance and data integrity requirements are being met.

Active surveillance of the USP & PE requirements to ensure timely updates of methods and collaboration with QA..

Implement critical corrective actions of the quality CAPA within the established and previously agreed deadlines

Define continuous improvement objectives through action plans translated into numbers

Implement and maintain raw material reduction testing conditions

Implement cross-functional optimization plans (development, purchasing, etc.) or specific to the Control Laboratory

Gather the results of the raw materials concerned, the fluids, the environment

Analyze trends, write reports and propose and engage all necessary action plans once approved by QA. Collect data to carry out annual product reviews

Health & Safety

Comply with the implementation of PPE and procedures

Apply a controlled hazardous materials management policy

Comply with the rules of handling and storage and the appropriate identifications

Enforce a policy to control exposure to chemical substances by laboratory employees

Develop and maintain a 5S approach to avoid safety issues

Manage the wastes according to the safety policies in place

Your profile

EDUCATION & EXPERIENCE:

Bachelor's degree required; Masters preferred

10-15 years in an FDA regulated environment; CMO preferred

5-10 years of supervisory experience required

Prior Quality Control experience in manufacturing, facility operation, laboratory compliance and quality systems.

Compensation range

115,000.00 - 130,000.00 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!