Manager, Quality Investigations
Onsite Position: Albuquerque, NM
Our client provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
Our client proudly offers:
- 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!
Summary:
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 site’s 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 our client’s 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 our client's 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
- 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
Our client 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. Our client is an E-Verify employer.