A career with MilliporeSigma is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
As Head of Quality and Control you will be managing the Quality Assurance, Quality Control, stability functions and personnel at the SAFC Madison site. You will oversee the preparation, implementation, and verification of procedures and systems designed to assure that active pharmaceutical ingredients (APIs) manufactured by SAFC are cGMP compliant. In this role you will be responsible for ensuring that internal, customer, ICH, and FDA requirements are being satisfied.
In addition, you will be repsonsible for document control, product disposition, audits, training, customer interactions, Quality Control laboratory operations, and stability program management. As Head of Quality and Control you will be expected to make recommendations for continuous quality improvement and find practical solutions to compliance issues.
As Head of Quality and Control other respnsibilities include:
- Implementing, leading, monitoring, and measuring critical quality systems for the organization, such as document control, change control, compliant handling, deviations/investigations, CAPA, etc.
- Maintaining knowledge of analytical instrumentation utilized for raw material, intermediate, and final product testing, including, but not limited to: HPLC, FTIR, GC, DSC, TGA, NMR, LC-MS, KF, Polarimeter, and UV-VIS Spectrophotometer
- Operating Procedure (OP) writing, review, change control, approval, issuance, annual review and organization of files
- Managing direct reports, which includes selecting new employees, acting on employee problems, conducting performance and development reviews, providing disciplinary action, coordinating or conducting training, establishing goals/development plans, and approving/scheduling work hours
- Interacting with customer representatives on projects to assure customer quality requirements are met and the necessary information/documentation is provided
- Reviewing/approving QC and Stability data and results
- Assisting with quality and regulatory audits by customers and state/federal agencies
- Handling customer inquiries and complaints. Preparing corrective actions and reports
- Organizing and conducting GMP training/orientation and maintenance of personnel training files
- Working in accordance with current GMPs and demonstrates proper laboratory safety and housekeeping practices, especially for the handling of potent compounds
- Coordinating and prioritizing sample testing with the Operations/Production department and schedules QC coverage as necessary to support manufacturing
- Maintaining accurate and concise records. Reviewing and approving the work of direct reports and documents prepared by Analytical in support of QC efforts
- Performing quality audits at, and communicates with, contract testing laboratories and/or vendors
- Ensuring an internal quality audit program is conducted to identify potential improvements and compliance issues and suggest corrective actions
- Maintaining knowledge of cGMP compliance as it relates to API manufacturing and testing. Implementing the necessary systems, procedures, documentation, and training to maintain cGMP compliance
- Responsible for the disposition of raw materials, intermediates, and final products
- Performing, and assisting QC/Analytical personnel in conducting, documented laboratory out-of-specification (OOS) investigations
- Ensuring that drug master files are prepared, when needed, and maintained per regulatory agency requirements
- Managing the stability program
- Assisting with preparation of annual product reviews
- Participating in SAFC global quality initiatives and programs, including the review and implementation of corporate policies
- Preparing annual QC, stability, and QA department budgets and monitors expenses throughout the year
- Working closely with the Analytical group during method transfers and when method troubleshooting is required
Who you are:
- You have a BS/BA in chemistry or related science
- You have 10+ years of experience in quality and compliance in a GMP (Good Manufacturing Practice) industry with at least 5 years of supervisory/management experience
- You have knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211 and/or ICH Q7A)
- You have demonstrated an understanding of analytical chemistry and laboratory procedures
- You are competent with Microsoft Word, Excel, and Access
- You are excellent with communication, organization, attention to details, and interaction skills.
ADDITIONAL LOCAL NEEDS:
- This position requires the ability to stand, sit, walk, bend, reach, lift, pull, push, speak, hear, and use hands to operate lab-testing equipment on a regular basis. Specific vision requirements of this job include close vision, color vision, and the ability to adjust focus
- This position will require the use of safety glasses/goggles/face shield, latex gloves, lab coat, safety shoes and other required personal protective equipment
- While performing the duties of this job, this position may be exposed to toxic or caustic chemicals and fumes or airborne particles
- The noise level in the work environment is moderate
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.