Qc Manager

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 Description

Responsible for managing Quality Control staff and directs day-to-day operation of QC laboratory in the Devens and North Andover, MA facilities. Is responsible for analytical activities associated with raw material and product testing/release, in-process and stability testing, laboratory equipment qualification, oversite of QC site of clinical and commercial GMP operations to ensure products are tested to comply with requirements ensuring safety and quality, analytics to support manufacturing from cleaning validation/verification to environmental monitoring.

This position is responsible for implementing and managing cGMP compliant practices in the laboratory environment as well as for deploying functional strategy within the department, providing framework for effective teamwork, setting objectives and ensuring development of QC laboratory personnel.

PRINCIPAL ACCOUNTABILITIES

• Manages day-to-day operations within the QC group in a fast-paced, dynamic work environment in compliance with current regulations and policies (FDA, OSHA, DEA, etc.)
• Formulates and meets quality control objectives. Sets priorities with Operations and other managers to ensure quality and timelines are met to ensure material and products are tested, reviewed and approved within the accepted time frames. Interprets data and resolves technical issues.
• Reviews, authors, and edits documents, including deviations, change control requests, SOPs, test methods and related technical reports necessary for laboratory operations.
• Actively participates with cross functional teams and shares information, as appropriate, with direct reports. Oversees QC-related compliance activates, including investigation closure of any OOS/OOT/Atypical Results/CAPA events.
• Actively directs/leads/performs investigations and implements corrective and preventative action plans.
• Implements procedures and optimal infrastructure to ensure compliance with all regulatory agencies. Serves as the department representative on regulatory audits.
• Provides accurate and timely delivery of data and support regulatory filings.
• Performs assessments of current systems, to provide guidance for impartments to or development of streamlined GMP systems.
• Champions the continuous improvement process, defining process improvement projects.
• Coaches, mentors, leads, and manages employees. Ensures that training and other personal development programs are in place for succession planning and the development of subordinates. Ensures that performance opportunities are managed through the performance management system.
• Provides leadership for supervisors, analysts, and technicians to optimize productivity and quality of work. Provides effective planning for department operations to include required resources, and the maintenance and communication of cycle times.

QUALITY/REGULATORY RESPONSIBILITIES

• Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
• Applies cGMP concepts in association with department specific responsibilities.
• Ensures all documentation produced is in compliance with cGMP standards.
• Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
• Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.

ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES

• Manages staff in full compliance with all appropriate EH&S policies and procedures.
• Responsible for departmental audit readiness and for participating in audits with internal Company groups, regulatory agencies, and customers.
• Ensures staff acts in accordance with EH&S policies, practices and procedures.
• Addresses staff issues accordingly if there are EH&S violations.
• Actively participates in root cause investigations on near misses and all incidents. Once identified, ensures corrective actions take place and compliance with Company policies and procedures, and all state and federal regulations occurs within the responsible department.
• Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA, etc.
• Implements, applies and places emphasis on EH&S concepts with department specific responsibilities.
• Demonstrated technical and procedural expertise and self-assuredness in applying EH&S policies and procedures.
• Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2025 principals into daily activities.

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Must be able to lift at least 10 pounds.
• Must be able to work standing up or walking off and on for an 8 – 12 hour shift.
• Must be able to perform fine motor functions such as accurately weighing and transferring small amount of chemical compounds.
• Must be able to handle chemicals including potent ones in a safe manner, while donning appropriate personal protective equipment.

Qualifications

• Required, BS or MS in Chemistry or related field
• 10+ yeas in laboratory environment, preferably in API in GMP environment including 5+ years managing team.
• Extensive technical experience in analysis of small molecules, demonstrated knowledge of modern analytical techniques (HPLC, GC, KF, IR, NMR, DSC) and wet chemistry.
• Expertise and know-how with laboratory equipment in order to train staff and troubleshoot issues when needed.
• Proven ability to lead and coach, and motivate employees, clearly communicate job requirements and effectively manage performance of staff.
• Proven team player with well-developed interpersonal, organizational, mentoring and communication skills, including written documentation.
• Knowledge of SAP, LIMS and project managements’ experience desired.
• Interest in learning and applying new techniques.
• Ability to change priorities in response to company demands while continuing to deliver exceptional work quality.
• Well-developed supervisory, organizational, skills.
• Requires a B.S. or M.S. in Chemistry or closely related discipline with extensive experience in Analytical and Quality Control support of Active Pharmaceutical Ingredient (API)

VALUED

• Experience with a range of organic analytical chemistry techniques, with particular emphasis on chromatographic methods, including HPLC, GC, IC, LC-MS, titrations, KF, NMR, FTIR, DSC and TGA. Experience with cGMP procedures.

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.