Manager, Quality

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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, CAPA's, Change Controls, Audit Records, APR's) across Commercial, Clinical, Supply Shain, and Client Services functional areas. Serve as the Site's Global Trackwise Administrator which includes generation 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 :

Bachelor's 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 (SOP's) 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 for tracking and, when necessary, authoring Investigations, Audit records, Annual Product reviews as 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 2 Data

Client Specific Metrics

Global Metrics

New Product Introductions

State License Status and adherence

Tracks open records in TrackWise to include Deviations, Complaints, CAPAs, observations, APR's and Change Controls to closure.

Responsible for managing workload distribution of writers to cover both Commercial and Clinical Operations and Supply Chain to ensure timely closure of Trackwise records.

As needed, support Commercial Operations by authoring investigations to support timely batch release.

Responsible for compiling and creating presentations for local, global and clients business and quality review. Identify 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 experience of direct reports.

Must be skilled in authoring investigations, CAPA's, 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 clinical and commercial packaging and distribution process along with awareness of regulatory documentation requirements preferred.

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 mission-enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.