Head of Quality Control - Top Pharmaceutical company – Wisconsin

Posted 24 May 2022
SalarySalary Competitive
LocationWisconsin
Job type Full Time
DisciplineSmall Molecule
Contact NameDhiren Patel

Job description

Mantell Associates is currently partnered with a global leading Pharmaceutical company, in their search for a Head of Quality Control.

Do you have experience in project or program management in the biotech industry or CDMO space?
Are you looking to join an international CDMO with plans to revolutionise biomanufacturing?

This is a leading CDMO who’s purpose is to solve the toughest problems in life science by collaborating with the global scientific community – and through that, aiming to accelerate access to better health for people everywhere. They provide scientists and engineers with best-in-class lab materials, technologies and services. They are dedicated to making research and biotech production simpler, faster, and safer.

Your role

As the Head of Quality Control (QC), you will be accountable for management of a GMP Quality Control Operations Department supporting custom starting materials, excipients and API manufacturing testing according to IPEC, ICH guidelines and applicable FDA’s 21 CFRs. In particular, ICH Q7, 9, 10, 11 and 12, 21 CFR 11, 210, 211 and 820 as applicable. You will oversee the Quality Control activities associated with material testing (finished product, intermediates, in process samples and raw materials), stability, equipment cleaning verification samples and environment monitoring and will be solely responsible for all quality staff which conduct these quality control activities within a Contract Development and Manufacturing (CDMO) Site.


Responsibilities

·         Manages a 24/7 Quality Control operations, consisting of 6 QC supervisors and a total of approx. 40 employees.

·         Manages the QC supervisors including training, recruitment, motivation, and performance management.

·         Ensures that all materials and products that require testing and release in the laboratory are done so according to agreed specifications and procedures in a cGMP environment.

·         Liaises with planning and project teams (internal and external) to create, maintain, and communicate the QC schedule.

·         Responsible for the safety of the quality control areas and operations.

·         Implement and manage a structured business process to ensure all QC work (standard/non-standard) is captured and up to date.

·         Ensures laboratory documentation and computerized systems comply with data integrity policies and regulatory requirements.

·         Understands Regulations and business processes required to maintain Laboratory Data Integrity.

·         Manages laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all QC and microbiological samples.

·         Leads the QC workstream of technology transfer as part of the CDMO business assuring the milestones of the projects are reached.

·         Manages the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per standard operating procedures (SOP).

·         Manages an effective QC documentation system. The QC Manager will prepare, review and approve documents as required.

·         Responsible for monitoring, statistically analyzing, trending and reporting of QC data/metrics to evaluate performance and risks

·         Actively engages with the Laboratory management teams to implement and maintain a system for capacity planning and demand forecasts.

·         Compiles data and develop analysis to support QC Investigations, KPIs and other QC Reports as requested. Develop and manage the department budget and capital expenditure budget

·         Leads and coach team members in Continuous improvement across planning, metrics and scheduling activities. Drive activities for improvement, development and troubleshooting of lab procedures and methods.

·         Represents QC matters during regulatory agency and customer inspections.

Minimum Requirements:

·         Bachelor’s degree in Chemistry, Chemistry Engineering, Pharmacy, Biochemistry, Biology or a related science.

·         5+ years of applicable experience – cGMP pharmaceutical quality control operations experience

·         Experience managing a team of direct reports

·         Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210, 211 and 820) and ICHQ7 Good Manufacturing Practice Guidance for APIs.

·         Knowledge in 21 CFR Part 11 and Data Integrity Guidelines for pharmaceutical manufacturing

- Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm.

- For more information on this role, please contact Dhiren Patel on +44 (0)20 3778 0990 or dhiren.patel@mantellassociates.com