Manager Quality Control

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives.
The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC laboratories, supervising testing processes, and ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations (FDA, EMA, ICH). This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing.

Job Description

ESSENTIAL FUNCTIONS:

• Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines.
• Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications.
• Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements.
• Maintain accurate records of all QC activities, including test results, deviations, and corrective actions.
• Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality.
• Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
• Prepare for and participate in internal and external audits, including regulatory inspections.
• Oversee calibration, validation, and maintenance of laboratory instruments.
• Provides subject matter assistance for LIMS, methods, testing, and validation.
• Manages QC testing group to achieve compliant testing in a timely manner.
• Manages Lab investigations and OOSs including remediation of potential compliance concerns.
• Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement.
• Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation.
• Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions.
• Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations.
• Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades.
• Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory.
• Ensures key turnaround timelines for customer service and compliance requirements are achieved.
• Performs as a subject matter expert during customer and regulatory audits.
• Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle.

• DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Develops and coaches to build talent.
• Participate in a 5S Workplace System to ensure good housekeeping and organization.
• Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
• Effectively trains others in a positive manner.
• Other duties as assigned with or without accommodation.

• MINIMUM REQUIREMENTS:

  Education:

  B.S. /B.A. in Physical Science required. 

  Master’s Degree preferred.

  Experience:

  10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current ­pharmaceutical cGMP requirements

  Preferred Skills/Qualifications:

  Other Skills/Competencies:

  Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories

  Experience with testing API or Pharma products

  Experience leading a group of up to 20 people with 24/7 shift operations

  Excellent written and verbal communication and leadership skills

  Ability to work in and promote a team environment

  Working knowledge of Six Sigma and/or Lean manufacturing tools

  Sense of urgency.

  Action oriented/drives for results

  Excellent communication and interpersonal skills

  Team orientation/strong team player

  Ability to coach, mentor and teach

  Excellent decision making, problem solving and analytical skills

  Strong managerial courage

  Ability to influence change at all levels of the organization

  Detail-oriented with the ability to work under tight deadlines

  Excellent conflict management skills

  Builds positive relationships with others

  Excellent time management and prioritization skills

  Excellent technical writing skills

  LIMS experience preferred

  Knows the difference between managing and leading and when to apply each

  Command Skills, Action Oriented, Conflict Management, Customer Focus,

  Problem Solving, Priority Setting, Written Communication,

  RELATIONSHIP WITH OTHERS/ SCOPE:

• Reports to Site Quality Director
• Work is performed without appreciable direction
• Develops strategic objectives for group managed
• Exercises considerable latitude in determining technical objectives of assignment
• Completed work is reviewed for desired results from a relatively long-term perspective
• Bias toward change, management of change, and achievement of results
• Contact with FDA as subject matter expert during site inspections and customers during frequent customer audits
• Regular contacts include Quality Assurance, Materials Management, Logistics, Commercial, R&D, Site Production Leaders and EH&S.
• This position has several direct reports

• WORKING CONDITIONS:

• 60% normal office and meeting room conditions.
• 40% Laboratory and Plant environment including exposure to raw materials and finished products.
• Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
• Some off shift and weekend work can be expected; travel requirements are minimal

• DISCLAIMER:

  The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.