Manager, Process Investigations

Location
Durham, NC, US
Posted
May 22, 2021
Ref
6047
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

The Manager, Process Investigations, is responsible for leading the Process Investigations Group that is responsible for the initiation, documentation, investigation and completion of non-conformances aimed at identification of root cause, and implementation of corrective actions and preventive actions and CAPAs, and continuous improvement plans.

Responsibilities

\u2022 Analyzes trends using statistical method.\u2022 Authoring/Owning/Ensuring investigations related to cell culture, purification, facilities and engineering.\u2022 Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers.\u2022 Perform/Review appropriate root-cause analysis for events utilizing investigation tool (e.g., 5 whys, Fishbone Diagrams).\u2022 Assign proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.\u2022 Utilize appropriate risk management tools for recommendation on disposition of materials.\u2022 Present completed investigations for final approval.\u2022 Performance of risk assessments.\u2022 Meeting facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.\u2022 Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of exception events.\u2022 Works on the manufacturing floor for data gathering, observing of processes for investigations, and interviewing employees.\u2022 Conducts personnel interviews and system reviews. Act as an unbiased investigator with questions surrounding the specific issue.\u2022 Remains current in regulatory expectations and industry practices regarding investigations and CAPA.\u2022 Tracks, trends and facilitates all manufacturing related deviations, investigations and CAPAs.\u2022 Supports manufacturing and Quality to assist in the data collection from manufacturing and preparation of necessary documentation to support Annual Product Reviews.\u2022 Hires, Manages, leads and coaches team.\u2022 Drives investigation processes, etc.\u2022 Provides direct technical/managerial leadership to Process Investigations group.\u2022 Represent Process Investigations Team on the monthly Quality Management Review meetings.\u2022 Presents investigations to regulatory agencies during inspections.\u2022 Other related job duties as assigned.

Qualifications

\u2022 BS degree in the sciences or related field and 8 years relevant experience or 12 years equivalent combination of education and experience.\u2022 Working knowledge of biopharmaceutical manufacturing processes\u2022 Excellent skill set in using statistical methods for analyze.\u2022 Ability to manage multiple ongoing projects concurrently.\u2022 Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.\u2022 Works in a cGMP environment and must have ability to understand and problem solve in an environment that is focused heavily on Chemical and Biological issues.\u2022 Understanding of the concepts incorporated in Quality Assurance in a GMP environment.\u2022 Excellent leadership and supervisory abilities.\u2022 Strong meeting facilitation and conflict resolution skills\u2022 Strong technical writing capability, be action oriented, and be compliant minded while ensuring completion of investigations.\u2022 Manufacturing, specifically upstream and downstream processing in a GMP environment is preferred.\u2022 Prior experience in quality investigations and deviation writing in a manufacturing environment.\u2022 Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.\u2022 Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting.\u2022 Must be proactive, action oriented, and have the ability to adapt to a change.\u2022 Must be able to identify and flag risks in a timely manner to keep deliverables on track.\u2022 Must have strong communication skills both verbally and written.\u2022 Must have proven logic and decision-making abilities, critical thinking skills.\u2022 Must have strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.

The level of this position will be based on the final candidate's qualifications.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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