Senior Manager, Quality Assurance

oxfordbiom•Durham, NC

About The Position

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Senior Manager, Quality Assurance Validation to join our Quality Assurance team. In this role, you will be responsible for leading the QAV team, ensuring conformance to established quality processes and standards while actively working to continuously improve them, playing a key part in advancing our mission and making a real difference.

Requirements

Expertise in support of Technology Transfer initiatives.
Bachelors’ and/or Masters’ degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
A minimum of ten (10) years of experience in the industry, ideally all clinical phases through commercial drug product.
Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation.
Knowledgeable of Data Integrity requirements.
Leadership skills to lead cross functional teams to ensure project success.
Excellent written and verbal communication skills including the ability to communicate, influence and negotiate across the organization.
Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
Ability to travel approximately 5-10% based on project demand.

Nice To Haves

Experience within a multi-product facility is a plus
Experience using risk based approaches (FMEA, PHA, etc).

Responsibilities

Has in-depth or breadth of expertise in product lifecycle, process validation, analytical methods, computer systems, tech transfers, shipping validation and broad knowledge of related functions developed from considerable work experience.
Leads team/workstream through navigating complex problems that have a broad impact on the business and successfully drives solutions to such things as quality systems, audits, inspections, change controls, and validation documents.
Proven ability to effectively lead team/workstream with a meaningful impact on critical goals.
Accountable for the performance and results of a Quality Validation area or workstream with a broad impact on the organization.
Provides guidance, review and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), protocols, data analysis, and final reports.
Drives the implementation of new policies and procedures to support quality systems.
Exercises judgment within and outside of defined procedures and practices to determine appropriate action.
Sound knowledge and understanding of FDA and foreign requirements and expectations.
Works closely with all site functional teams (Manufacturing, Facilities, QC, etc) responsible for protocol development and execution to provide QAV support.
QA Approval of change controls and validation documents e.g. Impact Assessment, Risk Assessment, Protocol, Report, and User Requirements.
Provides QA support for validation activities including: Technology Transfer Process Validation Analytical instrument qualification, use and maintenance Computer systems validation Equipment and Facilities commissioning, qualification, use and maintenance Cleaning validation