Manager, Quality Control

The Manager, Quality Control (RMS) is responsible for managing and coordinating Quality Control (QC) resources and activities within the operational arena, ensuring that established Quality standards, processes, controls and technical requirements are effectively implemented and consistently applied across operational sites and / or functions.

Working within the Quality Management System and Operating Model, with priorities established by Quality leadership, the role translates requirements into clear day-to-day activities and deliverables. The role provides direct leadership to QC personnel and works closely with Operations, Quality Assurance and other functions as required, to meet goals and organizational needs.

The role operates with a defined level of autonomy within its area of responsibility, using available data, technical knowledge and operational judgement to resolve routine issues, identify opportunities to strengthen Quality Management activities and make recommendations to the VP, Quality Control.

The primary focus is on day-to-day execution, Partnership with Operations and relevant departments, QC performance, team leadership, technical capability, investigations and practical improvement of Quality processes and controls.

Key Responsibilities

Quality Control Overview

- Manage & monitor the effective and consistent delivery of QC activities by translating Quality standards, requirements and priorities into clear day-to-day activities.
- Identify operational and quality risks, constraints and emerging issues and ensure appropriate escalations accordingly.
- Ensure QC activities are appropriately planned, coordinated and resourced.
- Provide recommendations to the Quality Organization and leadership on operational priorities and quality requirements.

- Provide technical guidance and support to QC colleagues.
- Ensure any auditing, testing, inspection, sampling, monitoring and other QC activities are performed in accordance with approved standards and procedures, where applicable.
- Ensure appropriate technical controls are maintained to support reliable, accurate and consistent Quality outcomes.
- Lead, or support with input into QC issues and investigations as required.
- Ensure issues are appropriately assessed, documented / recorded and escalated.
- Maintain knowledge of relevant regulatory, customer and internal requirements.
- Assure the use of data, evidence and technical knowledge in day-to-day team activities.

QC Performance and Reporting

- Review QC data to identify trends, recurring issues, variation and potential risks – driving performance improvement through partnerships and influence directly with organisational leaders and with your team members support.
- Provide regular performance reporting to your leadership and relevant stakeholders.
- Translate data and technical information into clear conclusions, actions and recommendations.
- Monitor completion of agreed QC actions and escalate delays or risks.
- Use performance information to identify areas where controls, practices or capability may need to be strengthened and where successes are noted, and why – ensuring support for delivery of objectives is embedded or provided.

Non-Conformances, Deviations, Investigations and CAPA

- Lead or support your team’s investigations relating to QC deviations and non-conformances, ensuring thorough documentation / recording.
- Ensure appropriate root cause analysis and corrective actions are apportioned and monitored through completion to QC issues, monitoring effectiveness of solutions implemented.
- Escalate recurring, significant or systemic issues which appear across the portfolios managed.
- Ensure relevant learning from quality events is incorporated into appropriate QC practices, controls, procedures or training.

Quality Risk and Controls

- Drive a risk based approach to prioritization of Quality issues within departments / sites / operational areas and projects / change control or management.
- Support Quality Assurance with information and evidence required for quality governance.
- Escalate material risks where they may affect quality, compliance, customers or operational performance.

Process and Quality Improvement

- Using data, identify practical opportunities to strengthen and continually improve QC processes, controls and working practices.

Process improvement within this role is focused on the effectiveness of QC execution and does not constitute ownership of a separate Continuous Improvement function or organisation-wide improvement programme.

Site and Operational Support

- Work closely with Operations and departments to ensure Quality requirements are understood and effectively delivered.
- Provide practical QC expertise and ‘hands-on’ support to operational teams.
- Participate in quality reviews and operational meetings where appropriate.
- Build effective relationships with operational leaders while maintaining appropriate quality standards and challenge.

Team Leadership

- Lead, coach and develop the QC team, managing the resources and people effectively, within the group.
- Establish clear responsibilities, objectives and performance expectations, considering succession planning throughout.
- Allocate work according to operational and quality priorities.
- Monitor individual and team performance.
- Promote collaboration and knowledge sharing within the quality organization and throughout your networks.

Stakeholder Management

- Build effective working relationships with the VP, Quality Control, Senior Manager, Quality Control, Quality Assurance, Operations and Site Leadership.
- Encourage and foster an organizational culture where teams learn from experience, address root causes and strengthen the way quality is delivered.

Other duties as assigned

Minimum Requirements

- Education: Bachelor's degree in a relevant scientific, technical and / or quality, engineering or related discipline
- 7 years working within an environment that encompasses significant regulatory compliance, or quality systems, ideally within life sciences, laboratory animal, pharmaceutical, biotechnology, CRO, or related industries, including leadership of or responsibility for quality programs and teams.
- Experience of working closely with animal welfare regulations, AAALAC standards, USDA requirements, and quality management systems and any localized equivalents globally.
- Experience managing, coaching or developing professional or technical employees.
- Experience in QC processes, technical standards, investigations and quality performance.
- Experience using data to identify quality issues, trends and risks.
- Experience working cross-functionally with Operations and Quality Assurance.
- Experience implementing practical improvements to quality processes or controls.
- Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.

Working Conditions & Physical Requirements

- Prolonged periods of computer and display screen use.
- Ability to read, interpret, and communicate information effectively.
- Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.
- Proficient in time management and resource planning.
- Ability to perform duties with minimal supervision.
- Ability to initiate and implement self-development efforts.
- Advanced ability to effectively interact with clients and regulatory personnel.
- Ability to work effectively across state / geographical boundaries
- Ability to travel to international locations (up to 20% or as needed)
- Overtime, weekend, and holiday work as required.

Critical Success Factors

- Customer Focus.  Identifies, prioritizes and anticipates customer needs and delivers relevant, value-add, solutions to meet and exceed them.
- Efficient.   Takes responsibility for own time and effectiveness.  Identifies what needs to be done and does it before being asked or before the situation requires it.  Able to work things out without having to be shown too often. Seeks opportunities to contribute appropriately without direction.
- Communication.   Able to communicate information and ideas clearly and articulately both in oral and written form. Uses appropriate language, style and methods depending on audience and the purpose of communication. Able to convey complex information clearly. Anticipates the information that others will need. Expresses ideas effectively.  Practices attentive and active listening.
- Collaboration.  Actively supports and contributes to the success of the team. Actively encourages and practices collaboration and cooperation on the team.  Shares information and supports other team members. Can get things done with and through others and set realistic objectives. Seeks opportunities to develop others.
- Relationship Builder.  Develops, maintains, and strengthens strong partnerships with others internally and externally, cross functionally, in person and remotely.
- Improvement Driven.  Inspires and generates new solutions and approaches to issues and challenges to maximize efficiency and effectiveness through everyday practice of root cause analysis and critical thinking problem solving; Continually works to refine skills and abilities; Builds on ideas of others to come up with new ways to address issues or problems; Generates creative new solutions and approaches to issues and processes.
- Organization and time Management.  Plans and prioritizes work, manages time appropriately to meet deadlines, follows up with others to ensure one’s own work and commitments are completed on time, deals with pressure and deadlines through good planning.

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience.  The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.

At Inotiv, our work helps advance the development of new medicines and therapies that can improve people's lives. As a leading global contract research organization (CRO), we partner with researchers to tackle complex scientific challenges, drive innovation, and help build a healthier, safer world. Bringing together scientists, researchers, technical experts, and business professionals, we provide the expertise and collaboration needed to move research forward. Our people make this work possible, and we value the knowledge, ideas, and contributions each person brings to the team. Whether you are starting your career or bringing years of experience, Inotiv offers opportunities to learn, grow, and play a meaningful role in advancing treatments for patients around the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.