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Director, Quality Operations

2 months ago

Devens, United States Veranova Full time
Company Description

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Job Summary

This position leads the coordination and planning for the Quality Operations function and Quality Control test labs for the site, in collaboration with site leadership, to assure the day to day Quality Assurance aspects of manufacturing, issue resolution and batch disposition of active pharmaceutical ingredients, intermediates, or other special projects meet the compliance requirements needed to serve the pharmaceutical industry and end patients.

Key Responsibilities / Accountabilities
  • Aids in the creation of the Quality Operations & Quality Control strategy and implementation of the strategy at the site.
  • Creates QC/QA workload planning, budgeting, headcount and resource loading based on required skill sets and available assets
  • Assures the standards and QA oversight of batch production monitoring, quality control and release requirements are executed to assure batch compliance with GMPs and regulatory filings. Including stopping manufacture or distribution of a product if necessary.
  • Leads or advises on root cause analysis performed to investigate manufacturing deviations, critical events, customer complaints, audit findings related to production or trends in quality metrics.
  • Assures compliance with QMS during production & testing including investigations, CAPA and Change Management.
  • Manages, coaches and develops site Quality team members to assure succession planning
  • Develop, improve, and revise Standard Operating Procedures (SOPs), and testing monographs.
  • Assure implementation and execution of LIMS, TrackWise improvements and other E-systems projects.
  • Manage stability programs to support commercial products as well as new submissions, according to the ICH guidelines and zone requirements.
  • Monitors documentation practices to assess data integrity during the production, testing, review of products for research or commercial use.
  • Actively engages or leads teams in product or process/ product technology transfers and method transfers across sites.
  • Engages with site teams to review Quality Performance metrics and recommend actions for continuous improvement.
  • Engages with peer across regions to coordinate/harmonize product monitoring and disposition requirements as well as evaluate investigation trends and audit findings within and across sites to facilitates team discussion on proper global CAPA.
  • Assures proper execution of process, product and method validation through review, guidance and approval of protocols and final reports verifying compliance with regulatory expectations.
  • Engages and leads discussions with customers as needed to resolve complaint issues, audit observations, or quality agreement terms.
  • Aids the sites during Regulatory Agency Inspections and customer audits. Assists with DEA compliance requests as needed.
  • Participate in Site leadership team to execute overall business priorities.
  • Carries out any other duties within the employee's skills and abilities whenever reasonably instructed.
Scope
  • This role is responsible for creation of the Quality Operations & Quality Control portion of the Operations Plant budget each fiscal year as well as execution to budget.
  • This role is also responsible for working with plant operations teams as a key decision maker, to resolve issues in a timely manner and assign appropriate corrective actions resulting in improved Right First Time production and delivery of the related financial results
  • This role is responsible for the overall independent planning, organizing and controlling the quality operations activity within the regional sites to aid in attainment of the expected monthly/ quarterly and overall fiscal year financial goals.
  • This role coordinates with Quality Management responsible for other sites as needed to assure global approach to customer outcomes, batch monitoring and testing as well as other production controls.
Qualifications

Required
  • BS or equivalent in Chemistry or related Science
  • Minimum 10 years experience within GMP Quality Assurance/Quality Control in an FDA/EMA regulated industry
  • Minimum 5 years directly managing performance and development of staff members
  • Minimum 3 years experience with batch production, control and disposition processes
  • Minimum 2 years experience with QC Laboratory testing
  • Expert knowledge in Root Cause Analysis, Investigations, CAPA and CAPA Effectiveness
  • Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
  • Expert knowledge in process validation, production equipment qualification, environmental controls, and change management
  • Experience with Microsoft Office applications, including Word, Excel and PowerPoint at a minimum
  • Experience with customer complaint investigations
  • Ability to work as a team leader in a matrix environment
  • Ability to communicate & collaborate effectively with all departments for the purposes of strategy development, issue resolution and continuous improvement execution.
  • Strong analytical reasoning, oral and written communication skills
  • 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 management
  • Ability to independently interact with customers, vendors, and regulatory inspectorates
  • Ability to effectively and efficiently resolve conflicts within team and across teams
  • Ability to collect and process data and information quickly to form decisions and create mitigation plans based on potential risk levels
Preferred
  • Experience within Drug substance manufacturing
  • Formal education in organic chemistry
  • Familiarity with project management and ability to lead improvement projects across multiple sites
  • Familiarity with TrackWise, Master Control, LIMS and ERP systems


Additional Information

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons 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 considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.