Manager Quality Control - Chemistry (Onsite)

Purpose and Scope

Manage the development and implementation of 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 staff, which includes investigators, instrumentation lifecycle specialists, sampling personnel, and the laboratory administrator.

Essential Duties & Responsibilities

• Organize, oversees and evaluates 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.

• Communicate priorities related to investigations, change controls, releases, ordering, instrumentation, and CAPAs generated in the QCC laboratories according to established timelines.
• Oversee the generation, documentation and compliance of deviations, investigations, CAPA change controls, ordering and instrumentation.
• Oversee the incoming sampling program.
• Conduct, authors or approves deviations related to QCC Analytical procedures to investigate root cause, determine impact and corrective and preventative actions.
• Perform data trending related to deviations and OOS to drive down recurrence.
• Reviews proposed changes to quality systems, procedures, methods, to determine impact to the laboratory.
• Collaborate with functional areas to ensure QCC instrument qualification, validation, and maintenance/engineering activities are performed in accordance with Tolmar procedures.
• Author, revise and approve controlled documents such as SOPs, specifications, test methods, protocols, reports, validation documents, submissions to regulatory agencies and work instructions.
• Author, review, and approve change controls related to method changes, specification revisions, and instrumentation.
• Perform impact and change assessments for laboratory related change controls, including responses to audit findings in EQMS.
• Review and approve purchase requests and invoices and ensure monthly budget adherence.
• Ensure back-ordered items are escalated and addressed in a timely manner.
• Ensure compliance with sample submission form review and verification.
• Ensure compliance with periodic review processes.
• Adheres to the department budget while managing exigencies, established company goals, and new market opportunities.
• Identify large-scale cost-saving measures to reduce overall costs.
• Provide guidance to project teams on the implementation of new laboratory systems.
• Lead the department with evaluation and implementation of new systems, and training for continuous improvement efforts.
• Collaborate cross-site and cross-departmentally to maintain effective and efficient processes, appropriate deployment of resources and ensure procedures are established and followed.
• Perform trending, reporting and communication of laboratory data including department KPIs , individual team performance metrics and progress towards department and company goals.
• Monitor and revise GxP systems currently in place to ensure compliance with established SOPs, policies, cGMPs and other relevant regulatory requirements.
• Enable and drive technical and transferable skill development and empowerment of employees while holding them accountable for activities required to meet deadlines.
• Manage, monitor, revise and approve new CBT content of the QCC training program.
• Participate in the hiring, mentoring, developing and retention of junior talent.
• Participate and lead by example to recognize and reward top performing talent utilizing established reward and recognition programs and systems.

• Participates in and supports development and implementation of Operational Excellence initiatives including tracking ROI of associated projects which enhance laboratory and staff efficiency.
• Assist departmental director in providing QCC oversight of compliance processes, including document review and approvals.
• Remains up to date with advancements in laboratory operations and lean excellence.
• Participate in daily and weekly project team meetings.
• Participate in third party and regulatory audits. Serves as a lead for internal audits of QCC.
• Generate Certificate of Analysis (CoA) 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 the 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.
• Expert knowledge of regulations related to deviations, investigations, CAPA, change control and instrumentation.
• 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 for conformance to US, EU and ROW standards.
• Expert in conducting investigations, writing deviations, implementing CAPA and initiating change controls.
• Experience working with suppliers to resolve issues related to sampling.
• Experience in monitoring and revising KPIs to consistently improve laboratory performance.
• Experience leading audits and inspections.
• Strong independent thinking, organizational and planning abilities and excellent analytical and problem-solving skills.
• The ability to define, drive, and implement change with strong adherence to deadlines when there are competing priorities.
• 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 Manager QCC is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor's degree in scientific discipline, preferably in chemistry or biochemistry and ten or more years in a pharmaceutical setting, or master's degree in a scientific discipline and 7 or more years a pharmaceutical setting.
• Four or more years of experience in a supervisory position required.

Compensation and Benefits

• Annual pay range: $120,000.00 - $135,000.00
• Bonus eligible
• Relocation benefits based on eligibility
• Benefits information: https://www.tolmar.com/careers/employee-benefits

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 to meet important timelines in a high throughput lab.
• Business demands may present a need to work extended hours at various 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.