Qa Compliance & Regulatory Manager

Job Description:
General Summary:
The Compliance & Regulatory Affairs Manager is a member of Quality Assurance, managing directly over the Compliance & Regulatory Affairs and Document Control Departments. This includes providing a lead role in the Compliance & Regulatory Affairs team, which oversees the Quality System (Auditing, Change Control, GMP Documentation & Quality Systems, Quality Metrics and Training) consistent with internal policies, SOPs, and industry practices, as well as supporting the company's regulatory and compliance requirements with domestic and international agency regulations. The position also provides technical expertise and guidance to multiple users throughout the company in using the document and Quality Management software systems in place at the company. Is well-versed with cGMP regulations and guidance documents.
Essential Duties and Responsibilities:

• Leads the Compliance & Regulatory Affairs group to develop, direct, execute and host Audits (Internal, Client Audits, etc.) to independently evaluate conformance to cGMP. Plans and executes readiness audits.
• Leads and/or participates in internal audits as part of an audit team.
• Assists or hosts client audits or regulatory inspections.
• Administers exercises and training for "Audit Readiness" to the Compliance group to ensure the Compliance Audit Program is prepared at an "all time" inspection readiness status.
• Ensures there are systems in place to assure that Compliance & Regulatory Affairs and Document Control personnel have adequate training, education, and experience to perform their GMP related job functions effectively.
• Provide GMP guidance to facility personnel.
• Creates, communicates, and supports commitment to quality and compliance standards/objectives.
• Develops strategy to foster site sustainable compliance and lead site regulatory inspection readiness.
• Supports and/or lead domestic or international regulatory inspections including the response to observations.
• Assists with identifying and resolving quality issues, addresses regulatory concerns, and accepts special projects and miscellaneous duties as required.
• Responsible for the development, execution, and management of:
  • Risk Management procedures/policies
  • Documentation control/Knowledge Management
  • QA/QC/GMP training and Contractor Qualification
  • Annual Reviews, Trend analysis, Metrics and Reporting
  • Process Improvement
• Provides technical expertise and guidance in GMP compliance
• Writes, revises, assists in writing and reviews SOPs.
• Ensures metrics are captured, organized, and systemically reported in support of Quarterly Management Reviews.
• Compile and maintain regulatory documentation
• Coordinate efforts associated with the preparation of regulatory documents
• Responsible for maintaining Quality Agreements and Annual Product Reports' required documentation.
• Responsible for maintaining and filing company registrations, licenses and/or certifications in a timely manner.
• Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires
• Analyze product complaints and make recommendations regarding corrective action solutions.
• Responsible for investigation and documenting adverse event reporting system per company SOPs.
• Coordinate recall or market withdrawal activities as necessary.
• Provides coaching and mentoring to subordinates.
• Administers performance reviews to subordinates.
• Other duties as assigned

Job Requirements:

• Bachelor's Degree with focus in physical or life sciences and 5+ years related work experience.
• Work experience must be relevant to Quality Systems experience (preferably working in an FDA regulated industry). 8+ years required if Degree is substituted w/ experience.
• Auditing related work experience and/or Quality Auditor Certification required.
• Supervisory or Managerial related work experience required.
• Ability to write correspondence for internal and external client communications.
• Comply with FDA and EU cGMPs and Regulations.
• Ability to speak effectively and communicate directly with all levels of personnel in the company.
• Excellent attention to detail, word processing accuracy, organizational and prioritization skills.
• Proficient with Microsoft Word, Excel, Outlook, Power Point, Adobe Acrobat and Automated Quality Management Systems (i.e., MasterControl).
• Ability to coach and mentor subordinates.
• Willing to work flexible hours to support organizational needs.

Physical Demands:
While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds.
Work Environment:
Work will occur in an office environment. The noise level in the work environment is usually moderate.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Cytovance Biologics acknowledges that providers may be a valuable resource for identifying and recruiting Candidates for employment. However, we require that all external recruiters engage directly with Cytovance Biologics Human Resources Team and comply with Cytovance Biologic's requirements prior to transmitting any Resumes/CV's or introducing any candidates to an employee of Cytovance Biologics. Cytovance Biologic's Human Resource Team is the only function within the Company that can enter contractual relationships with external recruiters and recruiting agencies.