Senior Manager, Validation

Exela Pharma Sciences•Lenoir, NC

About The Position

Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products. Lead the validation team in the establishment and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development and validation of new products, as needed.

Requirements

Must have exceptionally strong communication, interpersonal and project management skills
Ability to multi‐task and methodically manage projects in a fast‐paced manufacturing environment
Ability to lead a team of validation associates to prioritize and manage multiple projects across several product lines
Ability to manage consultants and set expectations for the quality and timeliness of their deliverables
Bachelors, Masters, or Ph.D. in Biochemistry, Biology, or related science field
Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing setting
Demonstrated application of FMEA, Risk Analysis, Validation principles, guidelines, and industry best practice
Demonstrated history of team management and effecting cross‐functional change with strong analytical problem solving and interpersonal skills
Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non‐technical audience
At least 8 years’ experience in the biotech/pharmaceutical industry in validation, quality management, process controls, and continuous improvement in an FDA‐regulated environment
A minimum of 4 years’ experience with aseptic and terminally sterilized products

Responsibilities

Plan, perform and coordinate validation projects to ensure timely completion
Responsible for drafting and providing technical guidance for the validation program, Policies and SOPs and other master documents
Support Engineering and Manufacturing in the development of critical process parameters and provide technical leadership for deviation investigations
Analyze data to provide recommendations for improvements in the manufacturing process and equipment
Assess new and existing processes (including Equipment IOPQ, Process, etc.) against cGMP and requirements for validation
Develop and implement strategies for equipment IQ/OQ/PQ, process validation, computer system validation and calibration
Perform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter experts
Oversee development and execution of validation protocols and review objective evidence for inclusion in validation reports
Assist with the technical assessment and resolution of deviances and variances that occur during production or validation
Work with Quality, Manufacturing, Regulatory, and subject matter experts to prepare for FDA and other agency audits
Ensure site/system validation program meets FDA, ISO and EU requirements
Collaborate with peers and stakeholders to in QA and Manufacturing to identify opportunities for process improvement
Facilitate communication and implementation of consistent processes across various product teams and global manufacturing sites
Provide updates to Senior Management on site validation status activities
Provide validation training to staff on validation protocols and standard operating procedures
Support investigations and implementation of CAPAs, as needed
Perform any other duties assigned