X-GEN Pharmaceuticals, Inc. continues to experience steady growth and this results in rewarding employment opportunities for candidates with the right skills. X-GEN Offers Pay and Benefits that Include: Vacation, Simple IRA, Professional Growth, Advancement and Health Insurance.
Title: QA Manager, External Manufacturing
Reports to: Director of Quality
This position is responsible for providing day to day quality input and oversight for successful life cycle development and commercialization of generic pharmaceuticals at external manufacturing partners globally and ensuring that the operational business is in compliance with cGMP, the Quality Agreement, regulatory requirements and X-GEN’s Quality Management System. The Manager, External Manufacturing, Quality Assurance, will act as the lead quality point of contact for assigned Projects.
- Supports X-GEN’s Mission and Vision statement by adhering to the Code Of Corporate Values and conforming to established performance expectations.
- Independently manage and provide quality oversite as well as lead daily quality related interaction and commercial production execution and/or product transfers with third parties and cross functional teams to assure:
- Quality and compliance related matters meet appropriate GMP and regulatory requirements
- Product is safe, pure and effective for distribution by direct review and inspection of the finished goods and documentation.
- All documentation for release is present, accurate and within established ranges and specifications
- Approval or rejection of product based on conformance to specifications, current Good Manufacturing Practices (cGMP’s) requirements and /or contractual agreements.
- Representation of the department and X-Gen on cross-functional project teams and external business partner meetings
- Compliance with cGMP’s, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third party contract manufacturers and external partners
- High performance of third party contract manufacturers by implementation of quality metrics and scorecard.
- Assures timely launch of new products by:
- Serving as the Quality lead for technical transfer activities at external manufacturing partners
- Reviewing ANDA filings for identification of deficiencies and compliance to the requirements
- Supporting manufacturing activities related to regulatory filings (i.e. on-site presence for engineering, validation, registration batch manufacturing, timely review and approval of documents, etc.)
- Participation in and advisement of responses related to filing deficiencies.
- Supports X-GEN’s Operations related to commercial product distribution by:
- Approving and releasing commercial product
- Leading investigations associated with product non-conformances and deficiencies identified during inspections, manufacturing, and product complaints
- Certifying that all incidents, complaints, and investigations are properly documented
- Verifying corrective actions for prevention of reoccurrence are completed in a timely manner and are consistent with the stated corrective action
- Investigating and determining the need for field alerts or recalls of company products manufactured by third party contract manufacturers
- Reviewing and approving quality records/documentation from third parties, including but not limited to product and process change controls (e.g., master batch records, API, raw material, product specifications, analytical methods), stability and validation protocols/reports, quality incidents and investigation reports, quality agreements and technical transfer documentation
- Perform on-site visits during manufacturing/packaging of X-GEN products and attend quality business reviews at external manufacturing partners to assess compliance with cGMPs and X-GEN’s requirements
- Participating in Agency and X-GEN inspections of external manufacturing partners to ensure successful inspection outcomes and maintain a constant state of inspection readiness at these sites
- Performing quality risk assessments and driving risk reduction improvement plans and remediation where necessary
- Driving quality compliance and performance metrics with external manufacturing partners and reporting metrics on a routine basis
- Compliance with cGMP’s, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third party contract manufacturers and external
- Performs other related duties as assigned or directed.
Bachelor’s Degree in science-Related (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering) 5-8 years of work experience in Quality Assurance within the pharmaceutical industry or 3-5 years of experience working with pharmaceutical Contract Manufacturing Organizations (CMOs) and business
Training (licenses, programs, or certificates):
- ASQ Certified Auditor (desirable, not required)
- Quality Assurance and Quality Control; cGMP; Contract Manufacturing (CMO); domestic and foreign regulations governing GMP plant operations and Relationship Management. Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines
- Proficient in reading, writing, grammar, and mathematics skills, interpersonal relations, communications skills, computer skills including Microsoft Office, Go to Meeting.
Travel: 50% domestic and international travel required
Title: Manager of QA Supplier Quality
Reports to: Director of Quality
This position is responsible for Quality Assurance external domestic and international Suppliers and/or CMOs by setting and implementing internal/external quality requirements to ensure X-GENs products and/or services meet cGMP’s and X-GEN’s and customer expectations.
- Supports X-GEN’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.
- Manages overall activity of the department and directly supervises assigned personnel as follows:
- Assists in the selection of new personnel as appropriate;
- Makes provisions for the proper orientation and training of new personnel;
- Reviews employee performance on a regularly scheduled basis;
- Develops recommendations for employee career planning and development and oversees process for individual skills assessment and continuing education plans;
- Coaches and directs personnel to ensure compliance with departmental goals, objectives and budgets;
- Conducts regular meetings and provides guidance and direction to personnel;
- Reviews employee’s time records, makes any necessary corrections, obtains appropriate signatures and submits for payroll processing;
- Organizes, schedules, prioritizes and distributes workload among assigned personnel;
- Keeps personnel informed of pertinent policies and procedures affecting the department and/or their jobs; Creates an atmosphere in which upward communication from employees is encouraged;
- Administers personnel policies and procedures as established by company policy;
- Manages cost center expenses as follows:
- Constructs budget within prescribed guidelines;
- Manages expenses to stay within budget; requests and approves payments depending on level of authority;
- Reviews expenses on a regular basis to ensure proper recording of account expenses;
- Explains variances, exceptions and other impacts that occur between budget and actual expenses;
- Conduct external cGMP or for cause audits of third parties and/or partners to ensure supplier quality-related activities relative to contracted labs, manufacturers, and distribution warehouses performance meets quality system requirements, and that those requirements are effectively established and maintained in accordance with cGMP, other worldwide regulations, as applicable, and X-GEN’s Quality Management System:
- Perform site inspections to drive improvement in supplier performance
- Audit, evaluate and qualify new suppliers
- Develop audit plan, conduct quality audit, prepare audit reports and communicate findings, including compliance risk
- Recommend approval or disapproval of suppliers based on compliance assessment.
- Review and evaluate supplier’s audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet specifications and quality requirements
- Follow-up on prior audit recommendations to ensure implementation and compliance
- Create, revise and maintain supplier quality standard operating procedures
- Author, manage and maintain supplier quality agreements and schedule
- Maintain the approved supplier list, supplier scorecard, and supplier audit schedule
- Drive compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed
- Conduct quality system audits of suppliers to identify potential areas of risks and drive continuous improvement
- Investigate customer complaints and for cause audit findings, gather and analyze data to determine root cause and implement corrective action to reduce or eliminate cause
- Actively monitor supplier quality metrics
- Actively participates in supplier quality related communication and feedback
- Perform Due Diligence visits/audits of potential new suppliers for X-GEN. Author and/or approve reports and provide recommendations regarding suitability and compliance of new suppliers. Propose any follow-up remediation or CAPAs relevant to the new supplier.
- Develop and maintain effective relationships with external suppliers and business partners to ensure timely audits, communication and resolutions.
- Make decisions and provide recommendations to senior management that have direct impact on the site and supplier quality and subsequent commercial manufacturing operations and/or product supply. Take appropriate actions to ensure any remediations are implemented.
- Performs other related duties as assigned or directed.
- Quality Assurance
- Internal Audit
- GMP Compliance
- Safety Compliance
- Environmental Compliance
- In-depth understanding of FDA trends, FDA and EU regulations and guidelines
- Data Analysis
- Proficient reading, writing, grammar, and mathematics skills;
- Proficient interpersonal relations and communication skills;
- Moderate computer skills: including Microsoft Office, Go To Meeting, MS Project
- Travel: Up to 60% domestic and international
- Bachelors degree in Science (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering) required.
- Minimum of ten years’ experience in Pharmaceutical Quality Assurance within the pharmaceutical industry with experience working with pharmaceutical Contract Manufacturing Organizations (CMOs), business partners and auditing.
- Must be certified auditor or have equivalent experience.
Application Procedure Candidates:
For consideration, please submit an electronic cover letter and resume, along with salary requirement, on our website. (email@example.com) Resumes and cover letters will be accepted until the position is filled.
Thank you for your interest in X-Gen Pharmaceuticals.
X-GEN Pharmaceuticals is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA.Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet
If you would like to submit a resume for future consideration, please use the form below.
300 Daniel Zenker Dr
Horseheads, NY 14845
+1 (866) 390-4411