Director, GMP ComplianceRacine, Wisconsin Job ID 11623 Apply
- The primary responsibility of the Director, GMP Compliance is to ensure compliance with Good Manufacturing Practices as it relates to Cosmetic, OTC, Drug, Food and Food Contact products at SC Johnson.
- This leader is responsible for developing, implementing, maintaining and assuring GMP Compliance.
- This individual provides strategic perspective and direction based on expert and up-to date understanding of GMP quality systems and industry best practices for both site and corporate quality initiatives.
- Assures that SCJ development and commercial products are manufactured and distributed in accordance with Good Manufacturing Practices (GMP) and applicable local regulations.
- Provides strategic direction to address compliance gaps and improvements to the SCJ Quality Management System (QMS).
Essential Duties and Responsibilities:
- Develops GMP standards for all sites at the corporate level tailored to the specific GMP requirements of products they are producing (E2E standards)
- Assures sites (internal and external) are complying to standard via audit programs
- Develops a skilled and highly motivated site GMP Quality Assurance organization via training and mentoring programs.
- Aids all sites in FDA audits, investigations and response letters required. In addition, develops global standard and RACI document to address how to handle FDA visits
- Evaluates all Gen 23 investigations as it relates to GMP failures to drive improvement
- Understands and is aware of all critical AE reporting and aids sites in ensuring proper investigations and incident management has occurred.
- Assures appropriate internal and external audits occurring and are evaluating compliance to applicable GMPs
- Ensures that compliance issues and their resolution are tracked and presented to management with executive responsibility on a timely basis
Required Skills / Experience / Competencies:
- Demonstrated competence in hosting health authority inspections required.
- Minimum of 15-20 years in GMP quality assurance roles
- Minimum of 10 years in a GMP leadership role.
- Expert knowledge of CGMP and strong knowledge of 21 CFR Part 11 (Electronic Records; Electronic Signatures) and equivalent international regulations
- Prior experience with OTC, Drug and Cosmetic products as well as exposure to food preferred
- Prior domestic and international experience preferred.
- Education – Bachelor’s degree in life sciences or related field required. Master’s degree in life sciences or related field preferred.
Preferred Skills / Experience / Competencies:
- Strong knowledge and understanding of the approach and perspectives of regulatory agencies.
- Must be able to interpret and apply existing and new/revised CGMP regulations and guidance independently.
- Extensive knowledge of FDA requirements and guidance regarding CGMP, product complaints, field alerts, and investigation.
- Excellent writing, communication and presentation skills with the ability to effectively present information to management.
- Ability to work both independently and in a collaborative team setting.
- Ability to influence global teams to execute against strategy
- Ability to multi-tasks and adjust priorities, as necessary.
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
- Demonstrated leadership and project management skills.
- Demonstrated understanding and experience working with international cultures.
- Full-time with expectation to be available for calls & meetings across time zones
- Variable global travel required, estimated to average 15-20% annually
SC Johnson & Son, Inc. is an equal employment opportunityand affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as a qualified individual with a disability, marital status, pregnancy, sexual orientation, ancestry, genetic information, or any other characteristic protected by law.
If you are an individual with a disability and you need an accommodation or other assistance during the application process, please call our Human Resources department at262-260-3343or email your request to SCJHR@scj.com. All qualified applicants are encouraged to apply. Download the EEO is the Law posterfor more information.