Head of Quality Operations

1 week ago

Devens, Massachusetts, United States Veranova L P Full time
Job Overview

Company Overview

Veranova is a prominent entity in the development and production of intricate active pharmaceutical ingredients (APIs) catering to pharmaceutical and biotech sectors. Our extensive technical knowledge and remarkable adaptability enable us to devise solutions and methodologies that foster and expedite innovation.

Position Summary

This role is pivotal in orchestrating and strategizing the Quality Operations function alongside Quality Control laboratories at the site. Collaborating with site leadership, the objective is to ensure that daily Quality Assurance operations related to manufacturing, issue resolution, and batch disposition of active pharmaceutical ingredients, intermediates, or specialized projects adhere to the compliance standards essential for serving the pharmaceutical industry and end patients.

Key Responsibilities

  • Contributes to the formulation of the Quality Operations & Quality Control strategy and its execution at the site.
  • Develops QC/QA workload planning, budgeting, staffing, and resource allocation based on necessary skill sets and available resources.
  • Ensures that standards and QA oversight for batch production monitoring, quality control, and release requirements are fulfilled to guarantee batch compliance with GMPs and regulatory submissions, including halting manufacture or distribution if required.
  • Leads or provides guidance on root cause analysis to investigate manufacturing deviations, critical incidents, customer complaints, and audit findings related to production or quality metrics trends.
  • Ensures adherence to QMS during production and testing, including investigations, CAPA, and Change Management.
  • Oversees, mentors, and develops site Quality team members to ensure effective succession planning.
  • Enhances, revises, and develops Standard Operating Procedures (SOPs) and testing protocols.
  • Guarantees the implementation and execution of LIMS, TrackWise enhancements, and other electronic systems projects.
  • Manages stability programs to support commercial products and new submissions in accordance with ICH guidelines and regional requirements.
  • Monitors documentation practices to evaluate data integrity during production, testing, and review of products for research or commercial applications.
  • Actively participates or leads teams in product or process transfers and method transfers across sites.
  • Collaborates with site teams to assess Quality Performance metrics and propose actions for continuous improvement.
  • Coordinates with peers across regions to align product monitoring and disposition requirements and evaluate investigation trends and audit findings to facilitate discussions on global CAPA.
  • Ensures proper execution of process, product, and method validation through the review, guidance, and approval of protocols and final reports, verifying compliance with regulatory expectations.
  • Engages in discussions with customers as necessary to address complaint issues, audit observations, or quality agreement terms.
  • Assists sites during Regulatory Agency Inspections and customer audits, including DEA compliance requests as needed.
  • Participates in the Site leadership team to implement overall business priorities.
  • Performs any other duties within the employee's skills and abilities as reasonably instructed.

Scope of Responsibility

  • This position is accountable for creating the Quality Operations & Quality Control segment of the Operations Plant budget each fiscal year and ensuring adherence to the budget.
  • This role is also responsible for collaborating with plant operations teams as a key decision-maker to resolve issues promptly and assign appropriate corrective actions, leading to improved Right First Time production and financial outcomes.
  • This position oversees the independent planning, organization, and management of quality operations activities within regional sites to support the achievement of expected monthly, quarterly, and annual financial objectives.
  • This role coordinates with Quality Management responsible for other sites as necessary to ensure a global approach to customer outcomes, batch monitoring, testing, and other production controls.

Qualifications

Required

  • Bachelor's degree or equivalent in Chemistry or a related scientific field.
  • A minimum of 10 years of experience in GMP Quality Assurance/Quality Control within an FDA/EMA regulated environment.
  • At least 5 years of direct experience managing staff performance and development.
  • A minimum of 3 years of experience with batch production, control, and disposition processes.
  • At least 2 years of experience in QC Laboratory testing.
  • Expertise in Root Cause Analysis, Investigations, CAPA, and CAPA Effectiveness.
  • Proficient knowledge of US & EU GMP, ICH Q7, and Part 11 compliance.
  • Expertise in process validation, production equipment qualification, environmental controls, and change management.
  • Familiarity with Microsoft Office applications, including Word, Excel, and PowerPoint.
  • Experience in customer complaint investigations.
  • Ability to lead teams in a matrix environment.
  • Effective communication and collaboration skills across departments for strategy development, issue resolution, and continuous improvement execution.
  • Strong analytical reasoning and oral and written communication abilities.
  • Capacity to plan, organize, prioritize, and monitor workload across multiple sites and customer projects.
  • Understanding of risk management principles and decision-making based on risk assessment.
  • Ability to interact independently with customers, vendors, and regulatory inspectors.
  • Skill in effectively resolving conflicts within and across teams.
  • Capability to swiftly collect and process data to make decisions and develop mitigation plans based on potential risk levels.

Preferred

  • Experience in drug substance manufacturing.
  • Formal education in organic chemistry.
  • Familiarity with project management and the ability to lead improvement initiatives across multiple sites.
  • Knowledge of TrackWise, Master Control, LIMS, and ERP systems.

Additional Information

All information will be kept confidential in accordance with EEO guidelines.

Veranova is an Equal Opportunity Employer, committed to providing equal employment access and opportunities to all individuals, regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully reviewed, and your details will be stored securely in our Application Management System, utilized throughout Veranova for selecting suitable candidates for our vacancies as they arise. Veranova respects your privacy and is dedicated to protecting your personal information. For more information about how your personal data is utilized, please refer to our privacy notice.

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