Quality Manager (Bioanalytical Lab)
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Lenexa, KS 66219
Pharmaceutical Research Associates, Inc.
Quality Manager (Bioanalytical Lab)US-KS-Lenexa
Job ID: 2019-54635
- of Openings: 1
PRA Health Sciences
Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA Bioanalytical Labs, with locations in Lenexa, KS USA and Assen, Netherlands, EU.
We are part of the 16,000+ employees strong for PRA Health Sciences, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
What will you be doing?
The Quality Manager provides coordination and leadership in the development, implementation and administration of the site’s quality management systems in accordance with all applicable regulations. Perform duties in accordance with company’s values, policies, and procedures.
• Coordinates and provides leadership for quality related items for a specific area/EDS site
• Actively participates and communicates cross departmentally regarding quality issues and processes
• Plans and coordinates the implementation and management of the company quality management system (excluding
audit activities) to ensure compliance with all applicable regulations (GCP, GLP, GMP (GxPs)) and applicable laws, to
meet the standards for clinical trials
• Oversees and manages/maintains, where applicable, appropriate documentation for all aspects of the company’s
quality management system to include but not limited to: internal and external audit findings and actions, CAPA
investigations and actions, quality control reports, quality management system metrics, quality policies, standard
operating procedures (SOP), training records, equipment management, computer systems and device records
• Oversees and manages internal follow up to internal and external audit findings and agreed actions e.g. sponsor,
FDA, EMEA, corporate, third party vendor audits
• Oversees and manages internal follow up to all CAPA investigations, agreed actions and effectiveness checks e.g.
sponsor, FDA, EMEA, corporate, third party vendors
• Oversees and contributes to the development of PRA EDS SOPs, WIs and other controlled documents
• Participates as the CAPA board chairperson if CAPA board established at sites
• Oversees direct and in-direct staff including training on ALCOA and good documentation practices, QC procedures,
fostering team building, positive communication, and corporate culture
• Oversees the management, delivery and documentation of internal operations and quality training
• (If applicable) Manages the quality team at sites and carries out supervisory responsibilities in accordance with the
organization’s policies and applicable laws. Responsibilities include workforce planning, assigning, and directing work;
appraising performance; rewarding and disciplining employees; addressing complaints, resolving problems and
relationship building through collaboration and partnership with operational functional managersLooks for ways to improve and promote quality
• Identifies and resolves problems in a timely manner
• Completes projects timely and within budgetary guidelines
• Speaks clearly and persuasively in both positive and negative situations
• Builds morale and group commitments to goals and objectives
• Sets expectations and monitors delegated activities
• Develops subordinates’ skills and encourages growth
• Aligns work with strategic goals
• Upholds organizational values
• Observes safety and security procedures
• Organizes, coordinates and monitors training curriculum programs with assistance from departmental managers and
What do you need to have?
Bachelor’s degree or equivalent in life sciences or related field.
Four years in early or late phase clinical research or a GxP regulated environment
Two years quality management or quality assurance experience in GxP environment
Strong knowledge of GxP’s (GLP, GMP, GCP)
Read, write and speak fluent English; fluent in host country language required
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities
Apply Here: http://www.Click2apply.net/dm6g8rqj95kyp6st