Quality Control Manager (Onsite)

Purpose and Scope

Manage the development, implementation and adherence to the policies, processes, and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Provide management oversight and leadership to the Quality Control Chemistry laboratory staff.

Essential Duties & Responsibilities

• Accountable for organizing, overseeing and evaluating daily QC Chemistry laboratory operations to maintain Quality Standards and project timelines, including prioritization and execution of work, coordination with internal and external stakeholders, and communication with leadership.
• Collaborates cross-site and cross-departmentally to maintain effective and efficient processes, appropriate deployment of resources and ensure test directives are established and followed.
• Performs trending, reporting and communication of laboratory data including department KPIs , individual team performance metrics and progress towards department and company goals.
• Monitors and revises GxP systems currently in place to ensure compliance with established SOPs, Policies, cGMPs and other relevant regulatory requirements.
• Enables and drives technical and transferable skill development and empowerment of first line supervisors while holding them accountable for activities required to meet deadlines.
• Communicates priorities related to the sampling, testing and release of pharmaceutical products, raw materials, and stability samples according to established timelines.
• Manages, monitors, revises and approves new CBT content of the QCC training program.
• Participates in the hiring, mentoring, developing and retention of junior talent.
• Participates and leads by example to recognize and reward top performing talent utilizing established reward and recognition programs and systems.
• Conducts, authors or approves deviations related to QCC Analytical procedures to investigate root cause, determine impact and corrective and preventative actions. Performss trending related to deviations and OOS to drive down recurrence.
• Reviews proposed changes to quality systems, procedures, methods, to determine impact to the laboratory.

• Participates in and supports development and implementation of Operational Excellence initiatives including tracking ROI of associated projects which enhance laboratory and staff efficiencies.
• Assists departmental director in providing QCC oversight of CMO processes, including document review and approvals.
• Collaborates with functional areas to ensure QCC instrument qualification, validation, and maintenance/engineering activities are performed in accordance with Tolmar procedures.
• Authors, revises and approves controlled documents such as SOPs, specifications, test methods, protocols, reports, validation documents, submissions to regulatory agencies and work instructions.
• Performs impact and change assessments for laboratory related change controls, including responses to audit findings in EQMS.
• Gathers information to support the budgeting processes and performs purchasing as requested. Reviews and approves operations laboratory expenses.
• Participates in daily and weekly and project team meetings.
• Participates in third party and regulatory audits. Serves as the lead for internal audits of QCC.
• Generates certificate of analysis and reviews stability reports as required.
• Maintains a safe working environment in the laboratory including reporting and trending of SOSPES observations.
• Maintains an atmosphere of teamwork, cordiality and respect towards coworkers.
• Participates in required annual hazardous waste training. Respond to spills per the Chemical Spill Procedures.
• Performs other duties as business demands.

Knowledge, Skills & Abilities

• Excellent leadership and supervisory skills with the ability to coach and mentor staff in order to develop skills and competencies required to meet business needs.
• Proficient knowledge in analytical testing of drug substances and formulations.
• Proficient knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
• Extensive knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP.
• Adept at applying cGMP in a QC chemistry lab for conformance to US, EU and ROW standards.
• Experience in conducting investigations, writing deviations, implementing CAPA and initiating change controls.
• Experience in monitoring and revising laboratory KPIs to consistently improve laboratory performance.
• Experience leading QC laboratory audits and inspections.
• Strong independent thinking, strong organizational and planning abilities and excellent analytical and problem-solving skills.
• Ability to define, drive, and implement change.
• Ability to effectively negotiate and deliver collaboration within teams and among team members.
• Demonstrated ability to create and maintain highly functioning teams.
• Proficient building and maintaining effective relationships and interpersonal/communication skills.
• Ability to coordinate activities to ensure both internal and external customer needs are met.
• Ability to consistently evaluate and deploy resources in the QCC laboratory to ensure all processes are adequately supported.

Core Values

• The Quality Control Manager is expected to operate within the framework of Tolmar's Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

• Bachelor's degree in scientific discipline, preferably in chemistry or biochemistry.
• Ten or more years in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting.
• Minimum of four years' experience in a laboratory supervisory position required.

Compensation and Benefits

• Annual pay range $120,000 - $130,000
• Bonus eligible
• Benefits information:

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Working Conditions

• Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput lab.
• Business demands may present a need to work extended hours at numerous sites.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.