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 Associate Director of Quality Investigations provides strategic leadership and oversight to ensure the efficient and effective execution of the deviation investigations process.  This role involves managing a dedicated team responsible for conducting thorough investigations into deviations and identifying trends.  This role is responsible for how the department develops, implements, and maintains investigation procedures to ensure compliance with regulatory requirements and internal standards. The Associate Director will initiate processes to ensure robust and timely investigations are executed according to procedures.  Key responsibilities include coaching, mentoring, and training staff on investigation techniques and methodologies, fostering a culture of continuous improvement and quality excellence.  Additionally, the Associate Director of Quality Investigations will act as the site Subject Matter Expert (SME), ensuring that investigators receive comprehensive training across various departments. This role guarantees the consistent application of best practices and contributes significantly to the overall success of the site's quality management system.

 Essential Duties and Responsibilities: 

• Provide strategic leadership to the Quality Investigations team, ensuring effective and efficient execution of deviation investigations.
• Manage a dedicated team responsible for conducting thorough investigations into deviations and identifying trends.
• Initiate and oversee processes to ensure that investigations are conducted promptly and in accordance with established procedures.
• Serve as the site Subject Matter Expert (SME) for investigator training, ensuring comprehensive training across various departments.
• Lead initiatives to improve the deviation management process and enhance overall product quality.
• Drive 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
• Champion Lean/Six Sigma principles related to process simplification and problem solving
• Contribute to CURIA's core values of Curiosity, Urgency, Respect, Integrity and Accountability 
• Interface with clients on investigation feedback and ensure continuous improvement
• Collaborate with cross-functional teams to identify root causes and implement corrective and preventive actions (CAPAs).
• 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:                                                          

• Bachelor's Degree in Engineering, Science or related field of study, preferred
• Minimum of eight (8) years of relevant work experience 
• Minimum of two (2) years' in a professional management role
• Minimum of six (6) years' experience in pharmaceutical and/or medical device manufacturing environment 
• A strong background in Lean and/or Six Sigma methodologies, preferred 
• Certification as Black Belt/Green Belt, preferred
• Experience writing complex investigations in related industry, 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.

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 position's 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.