Quality Control Manager Jobs

Overview
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-or-end analytical and logistical solutions.
The Quality Control Manager is responsible for leading and developing a team dedicated to the quality control of study support documentation and ongoing opportunities for improvement. This role is responsible for planning, implementation, and evaluation of the Quality Control practices within the Client Services team. The Quality Control Manager is responsible for managing the Quality Control team, including assignment, direction, and oversight of work. This role works closely with Client Services leadership, members of the Client Services team and Quality Assurance. This role ensures that trial design verification and quality review activities meet clients’ needs and ensures quality deliverables on time and within budget.
Responsibilities:

• Performs other related duties and tasks as necessary or as assigned
• Oversees creation of training materials for Quality Control
• Direct supervision of Design Verification Analysts and Design Verification Specialists. Supervises, coaches, develops, and retains talented team members
• Ensures responsibilities outlined within the protocol and contracted directly to LabConnect are carried out in an efficient and professional and compliant manner
• Interfaces with laboratory, customer service, business development, external project management, and information technology and data management personnel.
• Participates in the conceptual development of clinical trial projects during proposals, specification development and amendments to determine controls necessary to ensure quality project delivery
• Assigns study support documentation reviews to Quality Control team members, for thorough and timely completion
• Collaborates across departments to ensure QC reviews are consistent with current process and quality standards, identifying and managing risks introduced by process changes
• Writes, reviews and approves Project Quality SOPs, and may contribute to broader departmental SOPs to ensure appropriate quality measures are in place
• Updates project status to supervisor
• Develops and oversees design verification and quality review processes to ensure project designs are correct and meet the documented needs of clients per the OSD, protocol, and budget
• Oversees regular reporting of metrics related to quality control; establishes target limits and identifies data collection process for metrics
• Liaises and coordinates with the quality assurance department and subject matter experts on quality initiatives
• Participates in risk management for planned procedural departures or deviations that may impact project delivery quality
• Participates in feasibility assessments for scope and timeline related to project quality reviews
• Participates in quality event investigations to identify and remediate gaps in the quality control processes

Education, Qualifications and Skills:

• Proficient in Microsoft Word, Excel, and database software
• Global work experience with teams and clients across cultures and time zones is desirable
• Excellent listening and verbal comprehension skills, including ability to translate client needs to team members
• 2 - 5 years of client management experience in a central lab, contract research organization, and/or sponsor environment, preferably 4+
• Strong planning and problem-solving skills, ability to handle stress well
• Self-motivation and ability to work well independently as well as using a collaborative team approach
• Excellent organization, time management skills, communication, multitasking, and interpersonal skills
• Ability to make quick but well-thought-out decisions
• Bachelor’s degree in life sciences or related field required
• Ability to adhere to established timelines, processes, and procedures
• Excellent attention to detail and ability to adapt to changing environments and requirements as well as customer service skills
• Advanced working knowledge of Microsoft Office, including Word and Excel with the ability to learn and master company specific HR systems
• 2+ years of experience managing a team

Read more below and get ready for your next great employment adventure!
Some of the Perks our LabConnectors Love:

• PTO plan plus 10 Paid Company Holidays and 1 day to Volunteer in your community
• Health Benefits beginning on date of hire
• We celebrate our differences, which enrich our Culture
• Short- and Long-Term Disability, Life and AD&D
• Financial Security (base pay, 401k match and annual bonus eligibility)

We are a growing and global team on a mission to create healthier communities by accelerating the development of new medicines. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities.
We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world!
It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.
Equal Employment Opportunity Posters:
https://www.dol.gov/agencies/ofccp/posters.
If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email [email protected] or call (423) 722-3155.
For more information, visit www.labconnect.com