Director, Quality Operations and Quality Control

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time - Salary Devens, MA, US

3 days ago Requisition

Director, Quality Operations and Quality Control

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Every role at Veranova plays a part in delivering an exceptional customer experience through ownership and integrity.

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.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

The Director, Quality Operations and Quality Control leads the Quality Operations function and Quality Control test labs for the Veranova sites located in Devens, MA and North Andover, MA. In collaboration with site Leadership, it is the responsibility of this role to ensure the day to day Quality Assurance aspects of manufacturing, testing, reporting, issue resolution and batch disposition of active pharmaceutical ingredients, intermediates meet the compliance requirements applicable to drug substance manufacturing of pharmaceutical products.

This position is fully onsite first shift at our Devens, MA facility.

• Aids in the creation of the Quality Operations (QO) and Quality Control (QC) strategy and implementation of the strategy at the site; creates QC/QA workload planning, contributes to site budgeting, headcount and resource loading based on required skill sets and available assets.
• Assures the standards and QO oversight of batch production monitoring, quality control and release requirements are executed to ensure 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; ensures compliance with QMS during production and testing including investigations, CAPA and change management.
• Supports implementation and execution of LIMS, Track Wise improvements and other E-systems projects.
• In collaboration with Regulatory Affairs and QC, manages stability programs to support commercial products as well as new submissions, according to ICH guidelines and zone requirements; develops, improves, and revises Standard Operating Procedures, testing monographs, monitors documentation practices to assess data integrity during production, testing, review of products for clinical or commercial use; actively engages or leads teams in product or process/product technology transfers and method transfers across sites.
• In collaboration with site VP/GM, presents Quality Performance metrics to Executive leadership during quarterly management review meetings; engages with site teams to review Quality Performance metrics and recommend actions for continuous improvement; participates in site leadership team to execute overall business priorities; manages, coaches and develops site Quality team members for professional development and succession planning.
• Engages with peers across regions to coordinate/harmonize product monitoring and disposition requirements as well as evaluate investigation trends and audit findings within and across sites to facilitate team discussion on proper global CAPA.
• Assures proper execution of process, product and method validation through review, guidance and approval of protocols and…