Director, Regulatory Compliance
- Job Title
- Director, Regulatory Compliance
- Job ID
- 27727339
- Location
- Mainland, PA, 19451
- Other Location
- Description
-
Director, Regulatory Compliance, Full-Time
Job Function:- Incumbent ensures that site management is provided with current regulatory assessments of existing and emerging regulations, ensures that compliance risks are communicated in a timely manner, and develops action plan recommendations to address any changes that impact the quality system.
- Responsible for managing regulatory related tasks for all Accupac sites, including:
- Assisting customers in the completion of documentation that supports product registrations.
- Responding to customer supplier assessments and supplier management documentation.
- Review and completion of Quality Agreements in order to ensure a consistent approach to these across Accupac’s portfolio.
- Develop plan and procedures to establish Accupac’s regulatory compliance program, including establishment of procedures for handling FDA product listings for OTC, FDA, product listings for cosmetics under the MoCRA legislation, private label products and other listings as required by regulators in the markets that we serve.
- Perform risk assessments for proposed new product introductions in order to understand if the proposed product fits within the production matrix and does not pose an unacceptable risk to other product lines in the portfolio.
- Maintain process to ensure Accupac’s supplier quality program is in good standing with established procedures and customer requirements. This includes ensuring supplier documentation is maintained up to date and coordination with stakeholders to ensure questionnaires and supplier audits are executed per established procedures.
- Perform other duties related to the advancement of the quality system as assigned.
- BA/BS in relative scientific or technical discipline field
- Preferred area of study: Science or engineering, biological sciences
- Experience in a cGMP environment and related Quality field, 3-8 years
- Certification such as Certified Quality Auditor or Regulatory Affairs Certificate preferred.
- Knowledge of relevant GMP regulations: FDA 21 CFR 210, 211,1, ICH 13485, 21CFR820, familiarity with FDA procedures and MoCRA legislation.
- Strong focus on continuous improvement and quality, willing to work with others in a fast-paced environment, conscious of the need to implement improvements as a team.
- Strong interpersonal communication, ability to write in a clear, concise manner.
Physical Requirements:
- Possess the ability to work on a computer / laptop for extended periods of time.
- Possess the ability to carry documentation and boxes up to 25 lbs.
- Possess the ability to hear speech and/or alarms through plant noise
- Possess peripheral vision
- Possess eyesight with or without corrective lenses to discern differences in small type characters
- Possess the ability to recognize colors and shades of color
Supervisory Responsibilities: The position may require supervision of staff.
Travel: Occasional travel between Accupac sites.
Education and/or Experience: Must have a BA/BS Degree in relative science or technical discipline field, preferably Science or Engineering. Experience in a cGMP environment and related QA or Regulatory field, 7-10 years.
- Incumbent ensures that site management is provided with current regulatory assessments of existing and emerging regulations, ensures that compliance risks are communicated in a timely manner, and develops action plan recommendations to address any changes that impact the quality system.
- Required Skills
-
Minimum Requirements of the Job:
• BA/BS in relative scientific or technical discipline field
• Preferred area of study: Science or engineering, biological sciences
• Experience in a cGMP environment and related Quality field, 3-8 years
• Certification such as Certified Quality Auditor or Regulatory Affairs Certificate preferred.
• Knowledge of relevant GMP regulations: FDA 21 CFR 210, 211,1, ICH 13485, 21CFR820, familiarity with FDA procedures and MoCRA legislation.
• Strong focus on continuous improvement and quality, willing to work with others in a fast-paced environment, conscious of the need to implement improvements as a team.
• Strong interpersonal communication, ability to write in a clear, concise manner.
Physical Requirements:
• Possess the ability to work on a computer / laptop for extended periods of time.
• Possess the ability to carry documentation and boxes up to 25 lbs.
• Possess the ability to hear speech and/or alarms through plant noise
• Possess peripheral vision
• Possess eyesight with or without corrective lenses to discern differences in small type characters
• Possess the ability to recognize colors and shades of color
Supervisory Responsibilities: The position may require supervision of staff.
Travel: Occasional travel between Accupac sites.
Education and/or Experience: Must have a BA/BS Degree in relative science or technical discipline field, preferably Science or Engineering. Experience in a cGMP environment and related QA or Regulatory field, 7-10 years.
