Manager, Quality Investigations

4 weeks ago

Albuquerque, United States curiate.co Full time

Manager, Quality Investigations in Albuquerque, NM

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

We proudly offer

+ Generous benefit options (eligible first day of employment)

+ Paid training, vacation and holidays (vacation accrual begins on first day of employment)

+ Career advancement opportunities

+ Education reimbursement

+ 401k program

+ Learning platform

+ And more

The Quality Investigations Manager provides leadership and oversight to ensure effective execution of deviation investigations. This role involves managing a team responsible for investigating deviations and identifying trends, as well as developing and overseeing the deviation investigations process. The manager will ensure that investigations are conducted thoroughly and promptly according to established procedures. Additionally, they will coach and mentor staff, imparting the skills needed for successful investigations, and serve as the sites Subject Matter Expert (SME) for training investigators across departments.

Responsibilities:

+ Subject matter expert for GMP investigations

+ Leader to drive robust investigations that have adequate and robust objective evidence to support conclusions and appropriate actions

+ Supports product complaints, deviations, and failure investigations.

+ Develop and teach others on investigation methodology utilizing industry standards such as 5-why, cause maps, fishbone, FMEA, and/or 8 step root cause problem solving

+ Help to champion Lean/Six Sigma principles related to process simplification and problem solving

+ Contributes to CURIAs core values of Curiosity, Urgency, Respect, Integrity and Accountability

+ Interface with clients on investigation feedback and ensure continuous improvement

+ Help develop appropriate corrective and preventative actions (CAPA) based on root cause identification

+ Help establish sound criteria for CAPA effectiveness checks

+ Supports CURIA Compliance department during FDA and other agency inspections as well as customer and internal audits

+ Maintains a working knowledge of industry standards related to root cause analysis and problem solving

+ Ensure technical writing skills are properly developed for all investigators

+ Read/interpret SOPs to ensure compliance

+ Maintain up to date trainings

+ Other duties as assigned

Education and Experience:

+ Bachelors Degree in Engineering, Science or related field of study

+ Minimum of five (5) years experience in Quality Investigations or related field

+ Minimum of five (5) years experience in pharmaceutical and/or medical device manufacturing environment.

+ Background in Quality or Production, writing complex investigations, preferred

+ Strong background in Lean and/or Six Sigma methodologies, preferred

+ Certification as Black Belt/Green Belt, preferred

Supervisory Responsibilities:

This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.

Language Skills:

The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.

Other Skills and Abilities:

+ Leads with integrity and respect

+ Provides guidance, coaching, and mentorship to team members

+ Demonstrates business acumen

+ Fosters a collaborative and positive work environment

+ Champions change

+ Coaches and Develops

+ Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.

+ Demonstrates strong attention to detail

Other Qualifications:

+ Must pass a background check

+ Must pass a drug screen

+ May be required to pass Occupational Health Screening

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each positions physical requirements. Certain roles may involve climbing and working at elevated heights as well.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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