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Employment

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.

Equal Employment Opportunity Policy Statement

Equal Employment Accomodation Notice

Equal Employment Pay Transparency

Equal Opportunity Employment is THE LAW

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Title: Manager of Regulatory Affairs
Reports to: Director of Regulatory Affairs


FLSA:  Exempt

General Responsibilities:

Works directly with department and project personnel to ensure compliance and inform of updates to regulations.  Ensures that projects and proposals meet all relevant guidelines, standards, and regulatory rules, conducting research where needed.  Oversees preparation of all Regulatory submissions to FDA, including the review of data, testing procedures, and compliance aspects of proposals and reports.  Investigates and reports adverse events, compliance violations and similar problems.  Ensures company compliance with all regulations and laws pertaining to company business.

Essential Duties:

  • 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;
  • Oversees preparation, data, testing procedures and compliance aspects of proposals and reports.
  • Investigates and reports adverse events, compliance situations and similar problems.
  • Works directly with departments and project personnel to ensure compliance and inform of updates to regulations.
  • Ensures projects and proposals meet all relevant guidelines, standards, and regulatory rules, conducting research where needed.
  • In conjunction with the Director of Operations and the Director of Quality Assurance develops, implements, manages and evaluates regulatory strategy and tactics for all FDA regulatory submittal through the end stages of the product life cycle
  • Authors and critically reviews SOPs, protocols, technical documents, labeling, data and reports to ensure suitability for regulatory filing
  • Reviews product advertising and promotional material and analyze for compliance with current regulations
  • Monitors and investigates change in the regulatory environment through direct interaction with regulatory agencies, attendance at trade seminars, routine review of the federal register, FDA Internet updates and other trade publications to assess the impact on internal operations
  • Provides leadership to RA staff and continually reviews processes to streamline and improve company processes including performance issues and staff training needs
  • Performs other related duties as assigned or directed

Basic Qualifications:

Education:

Bachelor’s Degree in Chemistry or related science

Training (licenses, programs, or certificates):  

  • Regulatory Affairs Certification (RAPS-RAC) preferred but not required

Skills: 

  • People Management
  • Project Management
  • Quality Assurance/Quality Control
  • Regulatory Compliance
  • Documentation
  • Technical Analysis
  • Auditing

Proficient reading, writing, grammar, and mathematics skills
Proficient 
interpersonal relations and communication skills, including use of English language
Proficient computer skills including Microsoft Office, Go To Meeting, eCTD software, SPL Portal, DocuProof, Artwork Management software, Adobe Acrobat Professional

Travel:   30% domestic travel required  

Manager Qualifications:
Number Supervised: 5 people

Experience:
Minimum: 5 Years experience in Pharmaceutical Regulatory Affairs
Proficient: 10 Years experience in Pharmaceutical Regulatory Affairs

Physical Requirements:
Possess sufficient manual dexterity to be able to bend, sit, stand and reach with hands and arms; Visual and auditory skills required, including close vision, peripheral vision, depth perception and ability to adjust focus and ability to speak and hear. The employee must regularly lift and/or move up to 10 pounds.

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Title: Manager of QA Supplier Quality
Reports to:  Director of Quality

FLSA:  Exempt

General Responsibilities:

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.

Essential Duties:

  • 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.

Basic Qualifications:

  • Skills:
    • 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

Education/Experience:

  • 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.

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Application Procedure Candidates:

For consideration, please submit an electronic cover letter and resume, along with salary requirement, on our website. (careers@x-gen.us)  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.

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