Manager, Quality Compliance
The Manager of Quality Compliance will manage Deviations, NCMRs, CAPAs, OOS for the Quality Assurance department. The Quality Compliance Manager will handle customer complaints, support our internal audit program, work in collaboration with QA Central Functions to streamline processes, and effectively utilize tools of Quality Management Systems (QMS) to improve site compliance.
Essential Functions and Responsibilities:
· Coordinates, tracks, and supports the site quality to drive continuous improvement and resolve site compliance issues
· GMP Compliance Improvements
· Supports internal audits
· Establishes, tracks and presents Quality Metrics to support the Quality Management Review
· Translates compliance requirements from relevant FDA guidance, USP, ISO into executable quality procedures
· Serves as the SME on site Quality Systems and provides guidance and interpretation to internal stakeholders
· Provides guidance for higher-level decisions required for local change control, CAPAs, and Deviations
· Writing new and revising current standard operating procedures (SOPs), and specifications
· Provides support to customers and during regulatory audits
· Problem resolutions with GMP systems
· Bachelor’s Degree in a Science related field
· Minimum of 10 years’ experience in a cGMP environment
· Experience managing Quality Systems
· Must have skills for the critical assessment of SOP’s, investigations, and project protocols for content that will meet compliance requirements
· Ability to prepare reports for internal metrics and technical content
· Ability to critically evaluate data summaries and conclusions
· Must have competence of cGMPs, 21CFR 210, 211, ICH Q7 and USP-NF
· Strong working knowledge of Risk Management
· Must possess strong skill set to create charts and graphs using Excel
· Excellent written and oral communication skills
· Proficient computer knowledge, including Microsoft Word, Excel and PowerPoint
· Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
· Ability to successfully manage without authority in a cross-functional matrixed environment
· Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
· Detail oriented with the ability to troubleshoot and resolve technical and analytical problems
· Ability to work independently and manage one’s time
· Communicate effectively and ability to function well in a team environment
· Experience with Master Control
What We Offer
An exciting opportunity to dive in and begin your career with a company that offers a competitive total rewards package that includes:
· Full range of health benefits including medical, dental, vision and long-term disability
· 401(K) Safe Harbor Plan (3% company contribution, 100% vested)
· iPay Incentive Plan
· 11 Paid Company Holidays, Personal Time, Sick Leave and Vacation Time
· Travel to Switzerland for certain key positions
· Company sponsored events! (Summer BBQ and Holiday Party)
· Generous product discounts
Bachem recognizes that highly motivated and well-qualified employees are its most important asset. The competence, motivation and performance of individuals and the team are key to the development and long-term success of our business. We therefore strive to attract, retain and develop talented and committed people to all of our Group Companies. Bachem ensures equal opportunities for its employees and will not tolerate any discrimination.
This position requires the employee to regularly stand, walk, sit and talk or hear. The employee must also be capable of writing, using a computer keyboard, telephone and related office equipment. The ability to lift up to 25 lbs. is required.
The physical demands 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.
Within the facility, the employee will experience normal office conditions with a well- lighted work area and minor noise from standard office equipment. Occasionally the employee will experience unpleasant odors from the manufacturing facility. On a daily basis, the employee will visit the manufacturing facility several times. Lab coat and goggles will be required for these visits. The employee will constantly experience laboratory hazards. Very occasionally, the employee will be called upon to address emergency situations.
The above statements reflect the general duties/responsibilities necessary to identify the type and level of the position and are not intended to set forth all of the specific requirements of the position. Bachem is an at-will employer and as such reserves the right to revise or change job duties and responsibilities as the need arises and either party may terminate the employee/employer relationship at any time with or without cause.