Manager, Quality

CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time a concept that we internally embrace as There is a Patient Waiting. Our unique blend of services includes project management packaging distribution transportation management and specialty logistics ancillary supply management clinical supply optimization bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.

How will you make an impact

As part of our global team what you do contributes directly to our mission; enabling our customers to make the world healthier cleaner and safer.

What will you do

Management of a team of Technical Writers / Investigators who are responsible for managing Quality Records(Investigations CAPAs Change Controls Audit Records APRs) across Commercial Clinical Supply Shain and Client Services functional as the Sites Global Trackwise Administrator which includesgeneration of quality metrics and reports. Job duties also include analyzing tracking and trending the quality system metrics to support Sr. management with quality improvements.

How will you get here

Education:

Bachelors degree preferably with a technical or life sciences focus. Statistics preferable.

Responsibilities:

Performed statistical analysis such as regression clustering and hypothesis testing to uncover patterns in the data using programming language.

Tracks non-conformances and complaints and presents metrics to Senior Management on a scheduled basis.

Serves as a resource on regulatory issues compliance and internal investigations.

Conducts data analysis and data visualization to make actionable recommendations for Quality presentations.

Serves as quality lead in all client requested data and reporting needs from a site perspective.

Creates reporting and recommended actions for follow up on past due Quality Action Items such as Investigations etc.

Assist and makes recommendations with drafting and revising QA documents and Standard Operating Procedures (SOPs) as required.

Conduct all activities in a safe and efficient manner.

Other duties may be assigned to meet business needs.

Applies Good manufacturing Principles in all areas of responsibility.

Demonstrates and promotes the company vision.

Responsible fortrackingand when necessary authoringInvestigationsAudit recordsAnnual Product reviewsas required.

Responsible for generating tracking trending and reporting a large set of quality metrics relating to CTD- Allentown business operations and associated clients for continuous improvement purposes. These metrics include but are not limited to:

Quality Council Metrics

Tier 2Data

Client Specific Metrics

Global Metrics

New Product Introductions

State License Status and adherence

Tracksopen records in TrackWise to include Deviations Complaints CAPAs observationsAPRsand Change Controls to closure.

Responsible for managingworkload distribution of writers to cover both Commercial and Clinical OperationsandSupply Chainto ensure timely closure of Trackwise records.

As needed support Commercial Operationsby authoring investigationsto support timely batch release.

Responsible for compiling and creating presentations for local global and clients business and quality and implement continuous improvement initiatives within the site Quality System business processes.

Knowledge Skills Abilities:

Must have experience in GMP and pharmaceuticals Quality system and in-depth analytical thinking and understanding of metrics management.

Must be able to effectively prepare reports presentations metrics and communications with interpretation of data analysis and potential problems with clarity and high level of accuracy.

Most have strong technical writing authorship and be able to review reports while effectively inputting and expressing Quality risk management risks.

Must be skilled in decision-making building relationships problem solving planning and organizing. Must possess an independent mindset.

Should have management experienceof direct reports.

Must be skilled inauthoring investigationsCAPAs change controls audit responses.

5 years of experience performing either data management data analytics data visualization at one of the following industries is strongly preferred: Clinical research organization technology consulting firm pharma medical device or biotech organization

Excellent verbal and written communication and communicate effectively with customers.

Understanding of the clinicaland commercialpackaging and distribution process along with awareness of regulatory documentation requirementspreferred.

Mastery of skills required to read understand and adhere to the SOPs and policies of a GMP environment.

Physical Requirements:

This position is administrative and is positioned in an office environment.

It requires standing bending reaching walking and talking as well as exerting up to 20lbs.

Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.