Associate Director QA

The Associate Director is responsible for the management, execution, and leadership of quality activities for large molecule programs to ensure compliance with cGMPs, applicable worldwide regulations, and the requirements for supported area(s). The Associate Director is also responsible for providing assessments to senior management as to the compliance status and risk posture of supported area(s), Due Diligence programs, and guidance on alignment of policies and procedures with current regulatory expectations. Additional responsibilities include supporting the development of capacity planning and annual Profit Plans and ensuring department financial goals are met. The Associate Director may also operationally supervise Development Quality staff, contingent employees, or loan labor.

The Associate Director is to Fremain informed of current GMP requirements and industry trends in the large molecule (specifically biologics) processing and analytical areas to applicable worldwide regulations and industry standards. Provide comments on proposed regulations and communicate impacts to client areas using a risk-based, phase-appropriate approach for decision making. Maintain an expert level of knowledge related to specialized area of technical expertise, specifically for biologics.
- Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensure periodic updates, as appropriate.
- Manage the audit and/or approval of GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer, facility and/or equipment qualification. Ensure compliance with regulatory and requirements. Evaluate deficiencies and assess impact on compliance status.
- Coordinate preparations for regulatory agency inspections, as applicable. Accompany regulatory agency officials conducting inspections of facilities or operations in supported areas, including GMP Certification inspections and issue formal reports of inspection activities. Facilitate inspections by corporate auditors or external, non-government auditors in supported areas. Coordinate the drafting of responses to inspectional observations to satisfy our company’s and/or regulatory agency requirements.
- Advise supported areas on the GMP compliance aspects of the design of facilities, selection of equipment (including computerized systems), preparation of departmental SOPs, quality practices, policies, and interpretation of applicable worldwide regulations.
- Act as Quality representative for in-house or outsourced manufacturing programs. Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc.
- Support of Due Diligence/outsourced programs including travel to other countries (e.g., EU). Travel may be 5% depending upon program needs.
- Efficiently manage all activities within resource constraints while complying with all the policies and regulatory requirements.
- Develop/approve quality system and/or policy for Development Quality department as needed.
- Represent the department or area on project teams or committees establishing GMP, or quality standards, policies, or expectations within our company.
- Manage GMP audit/inspection program for facilities, systems (including computerized systems) and operations at contractors or licensees, engaged in the processing, testing, or holding of clinical supplies. Evaluate deficiencies and assess impact on compliance status. Issue reports summarizing deficiencies and work with departments to resolve such deficiencies. Notify appropriate Quality and support area management of compliance issues and performance trends.
- Specific and/or additional duties may include, but are not restricted to:
Assess the suitability of GMP data and material potentially available for use in clinical trials through the establishment of license agreements and advise Senior Staff on recommendations. Work with licensee on the identification of information required for the reviews of such programs.
- Manage the clinical release or re-evaluation dating to ensure conformance to appropriate worldwide regulatory requirements.
**Education Minimum Requirement**: B.S., M.S. and/or PhD. degree in an appropriate Science or Engineering discipline. Minimum of 8 years’ experience with B.S./M.S., or five (5) years with PhD.
**Required Experience and Skills**:Experience in pharmaceutical/biotechnology industry with five (5) years in a technical, quality or compliance role. Extensive working knowledge of GMPs and technical aspects of support area are required.
**Preferred Experience and Skills**: Effective communication, negotiation, problem-solving, and interpersonal skills with demonstrated project management abilities are necessary to perform job responsibilities. Previous experience required to perform job responsibilities may include: quality assurance, au