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Director of Compliance

2 months ago

Pennsville Township, United States Manpower Engineering Full time

 

 

Job Title: Director of Compliance 

Location: Pennsville NJ

 

SUMMARY:
The incumbent is responsible for the management of all aspects of the Quality Assurance, Regulatory Affairs, DEA, Quality Systems, and Validation at the Pennsville, NJ site. 

ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
Operational:

  • Certifies that products are of the quality required for their intended use, incorporating cGMP and other drug regulatory requirements.
  • Certifies that quality and regulatory procedures, policies, and systems are developed and implemented, ensures that training of appropriate personnel in the application of these procedures, policies, and systems take place, and ensures that all procedures, policies, and systems stay current.
  • Provides regulatory guidance and assessment of activities associated with the manufacture of bulk pharmaceutical products.
  • Interacts with technical departments, customers, suppliers, and regulatory agencies (e.g. FDA) in the review of issues and data.
  • Prepares and supports regulatory submissions.
  • Manages implementation and adherence to all applicable S&H and cGMP regulations
  • Develops departmental budget and cost controls and is responsible for meeting the agreed-upon budget.
  • Ensures the efficiency and continuous improvement of business processes pertaining to the department.
  • Coordinates all DEA and security activities through supervision and delegation to ensure that all CFR regulations are met
  • Leads all DEA on-site audits with the support of the DEA Manager
  • Incumbent is the main point of contact for the FDA auditors, visitors and interactions
  • Leads the US FDA inspections on site
  • Ensures that personal and departmental moral, ethical, legal, and behavioral conduct is in compliance with      the Siegfried Code of Conduct.
  • Provides mentoring and guidance to the Quality Analytical, BD, Engineering and Operations Departments for compliance with regulatory affairs and internal compliance practices
  • Addresses all other responsibilities that may be necessary to fulfill the duties associated with the position   or as may be assigned.

Strategic:
  • Participates as a member of the senior management team in the implementation of strategic directives.
  • Collaborates with colleagues in defining and structuring strategic measures.
  • Participates in defining and controlling strategic measures and cost management.
  • Supports validation of new and existing processes
  • Participates and collaborates with Process Development to contribute to inquiries of new processes


Page 2 of 2
Job Description:  Director Compliance

SUPERVISION:

The incumbent directly supervises a Sr. Quality Assurance Manager, a Quality Systems Manager, a Sr. Regulatory Affairs Expert, Computerized Systems Validation Expert, and a DEA Manager.  Is responsible for performance management, training and coaching of the entire Compliance Department. 

EDUCATION AND EXPERIENCE:
  • A Bachelor's Degree in Organic Chemistry, Chemical Engineering or equivalent, Master's preferred
  • 10+ years of managerial experience in a cGMP, bulk pharmaceutical (API) environment, preferably, but drug product candidates will be considered
  • Must have working knowledge of Regulatory Affairs.
  • Knowledge of DEA regulations and inspections is a big plus.
  • Must have hands-on experience with:
  • Facility and laboratory inspections (Customer and FDA)
  • Pre-approval inspections (FDA)
  • Process, product, equipment, automated system and computer (Part 11) validations and/or qualification inspections (FDA)
  • Authoring or responding to 483 reports, warning letters, consent decrees, FDA.

OTHER REQUIREMENTS:
  • Excellent verbal and written communication skills.
  • Able to work efficiently with people across all levels and cultures.
  • Excellent coaching and interpersonal relationship skills.
  • A self-starter, initiator, and team player.
  • Excellent project management skills.
  • Willing to travel on occasion.
  •  

 

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you

 

About ManpowerGroup, Parent Company of:  Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.