Quality Operations Director

7 days ago

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

Company Overview

Veranova is a prominent global entity specializing in the development and production of intricate active pharmaceutical ingredients (APIs) tailored for pharmaceutical and biotech clients. Our extensive technical knowledge and remarkable adaptability enable us to create solutions and processes that foster and expedite innovation.

Position Summary

This role is pivotal in orchestrating and strategizing the Quality Operations and Quality Control laboratories at the site, collaborating closely with site leadership to ensure that daily Quality Assurance functions related to manufacturing, issue resolution, and batch disposition of active pharmaceutical ingredients, intermediates, or specialized projects align with the compliance standards essential for the pharmaceutical sector and end patients.

Key Responsibilities

  • Contributes to the formulation of the Quality Operations and Quality Control strategy and its execution at the site.
  • Develops workload planning, budgeting, staffing, and resource allocation based on necessary skill sets and available resources.
  • Ensures adherence to standards and QA oversight of batch production monitoring, quality control, and release protocols to guarantee batch compliance with GMPs and regulatory requirements, including the authority to halt production or distribution when necessary.
  • Leads or provides guidance on root cause analysis to investigate manufacturing deviations, critical incidents, customer complaints, and audit findings related to production or quality trends.
  • Ensures compliance with Quality Management Systems 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 ensure data integrity during production, testing, and product review for research or commercial purposes.
  • Actively participates or leads teams in product or process technology transfers and method transfers across various sites.
  • Collaborates with site teams to assess Quality Performance metrics and propose actions for continuous improvement.
  • Coordinates with peers across regions to harmonize product monitoring and disposition requirements, as well as evaluate investigation trends and audit findings to facilitate discussions on global CAPA.
  • Ensures proper execution of process, product, and method validation through review, guidance, and approval of protocols and final reports to verify 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 support for DEA compliance requests as needed.
  • Participates in the Site leadership team to fulfill overall business objectives.
  • Performs any other duties within the employee's skills and abilities as reasonably instructed.

Scope of Role

  • This position is accountable for the creation of the Quality Operations and Quality Control segment of the Operations Plant budget each fiscal year and its execution.
  • This role serves as a key decision-maker, collaborating with plant operations teams to resolve issues promptly and assign appropriate corrective actions to enhance Right First Time production and achieve related financial outcomes.
  • This position is responsible for the independent planning, organization, and management of quality operations activities across regional sites to support the attainment of expected monthly, quarterly, and annual financial goals.
  • 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 the performance and development of team members.
  • 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.
  • Working knowledge of US & EU GMP, ICH Q7, and Part 11 compliance.
  • Expertise in process validation, production equipment qualification, environmental controls, and change management.
  • Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
  • Experience in customer complaint investigations.
  • Ability to lead teams effectively in a matrix environment.
  • Strong communication and collaboration skills across all departments for strategy development, issue resolution, and continuous improvement execution.
  • Excellent analytical reasoning and communication skills, both oral and written.
  • Ability to plan, organize, prioritize, and monitor workload across multiple sites and customer projects.
  • Familiarity with risk management principles and capable of decision-making based on risk assessment.
  • Ability to interact independently with customers, vendors, and regulatory inspectors.
  • Capacity to resolve conflicts effectively within and across teams.
  • Ability to quickly collect and process data to make informed decisions and develop mitigation plans based on potential risks.

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.
  • Experience with 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 opportunity 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 thoroughly considered, and your details will be securely stored 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 used, please refer to our privacy notice.

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