A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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.
The Quality Assurance Manager is responsible for managing Quality Assurance employees and all quality aspects associated with API manufacturing and regulatory requirements for the manufacture of clinical and commercial APIs and other materials. Also, direct multiple teams of quality assurance supervisors or individuals, in collaboration with project management, business development, EH&S, manufacturing, analytical, quality control, regulatory, and other teams, to achieve company and divisional goals for API and medical device compounds that ensure the growth of the corporation. Areas of emphasis include but are not limited to people management and oversight and implementation of the Quality Management System.
The scope of this position is to participate in the preparation, implementation, and verification of systems designed to assure that active pharmaceutical ingredients (APIs) manufactured by SAFC are cGMP compliant.
- Total sales revenue supported: Approximately $50 million
- Total number of employees supervised: Approximately 8 direct and 20 in department
- Number of locations responsible for: 2 (Madison & Verona)
- Total operating/department budget: Approximately $1 million
- Total capital expenditures: Approximately $1 million/year
Essential Job Responsabilities
- Assist the Quality Director in overseeing and managing all quality assurance systems within the facilities.
- Develop and maintain a staff of qualified professionals to monitor, modify and report on the effectiveness of the Quality Management System.
- Maintain and communicate a clear quality vision for the safe and efficient production of APIs and other GMP compounds.
- Review, establish, and monitor timelines and resources for the Quality Assurance team to ensure the assigned tasks are performed in a compliant manner within the assigned timeline.
- Ensure timely reviews of your team. Set department objectives and ensure team members have individual objectives.
- Support all site Health, Safety and Environment initiatives and requirements.
- Investigation reporting including deviations, OOT/OOS, and customer complaints.
- Review and approval of batch related documentation and final product release.
- Provide guidance and consultation to operations management in the areas of regulatory compliance and industry expectations.
- Provide QA input and manage as appropriate validation programs.
- Ensure the cleaning validation protocol and programs are in alignment with current industry standards.
- Support QA audits, inspections and investigations in a timely manner.
- Investigate customer complaints and regulatory queries in a thorough and timely manner and implement corrective and preventive actions.
- Lead and train QA team on detailed root cause analysis investigations related to relevant site and product quality requirements.
- Support preparation of APRs, DMFs, and other recurring cGMP requirements in a timely manner.
- Maintain an up-to-date knowledge of current international cGMP trends and cascade this to all reports and site leadership.
- Maintain and provide quality system metrics.
- Oversee the change control system.
- Drive, support, and monitor process improvement initiatives.
- Direct quality assurance department needs, review and adjust as needed to align quality and business goals.
- Act as liaison point with regulatory agencies as necessary.
- Act as lead host in regulatory agency audit in the absence of the Quality Director.
- Prepare, author, manage and ensure delivery of the company cGMP training program.
- Establish and manage the quality assurance budget by setting guidelines for salaries, supplies, travel, entertainment, and other budget items to stay within budget.
- Coordinate and align the quality assurance budget with corporate goals.
- Maintain all department HR related counseling, reviews, job descriptions, etc.
Who You Are:
- Minimum of a BS degree in a scientific field with a minimum of 5 years experience in GMP manufacturing, validation, QA, QC, or other functional area applicable to the job.
- Background in cGMP pharmaceutical manufacturing setting/ medical device facility and quality systems. Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines; ISO standards, etc. Excellent knowledge understanding of RCA and determining appropriate CAPAs. Previous role(s) related to supervising/employee oversight.
- Strong organizational skills, excellent verbal and written communication skills, and demonstrated leadership ability are required. Must be able to provide presentations regarding overall quality systems to customers or potential customers. Must be able to assess quality systems, evaluate quality systems for conformance to corporate and regulatory guidance, and proficiently discuss quality systems with customer representatives.
- Some travel may be required to attend conferences and meet with customers.
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 https://jobs.vibrantm.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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.