Responsible for scheduling and leading corporate audits including internal audits of GRAM facilities and external audits of GRAM suppliers in accordance with policies and procedures. Identifies top compliance risks and communicates to management. Must be able to function independently with limited supervision.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Lead internal audits of GRAM facilities based on the FDA System Based Inspection Policy and general cGMP. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings, including compliance risk.
- Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.
- Lead gap assessment audits and PAI readiness inspections at GRAM facilities as needed.
- Prepare monthly reports of completed activities including trend analysis, if required and submit to management.
- Lead external audits of raw material suppliers including contract laboratories, APIs, excipients, primary and secondary Packaging and sterilized goods. Develop audit plan, submit audit agenda, conduct quality audit, prepare audit reports and communicate findings, including compliance risk. Recommends 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 GRAM specifications and quality requirements. Follow-up on prior audit recommendations to ensure implementation and compliance.
- Assist in the maintenance of the annual internal and external audit schedules as requested by management.
- Assist in and/or lead the development of compliance and quality training as required.
- Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete required audit tasks.
- Lead for-cause audits of external suppliers as required.
- Actively support regulatory inspections as preparation coordinator. Respond to, coordinate and fill requests, organize SMEs in support of regulatory inspections.
- Actively conduct audits of third-party providers (GMP suppliers, contract laboratories, service providers) including paper audits and on-site audits. Travel is ~ 20% of the time.
- Open to a flexible and fluid work environment. Work on any assignment as directed.
- Support Agency, customer and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
- Must be computer literate and proficient in technical writing.
- Proficiency in both written and verbal communication and presentations.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented with sense of urgency.
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
- Ability to work with a diverse customer base and interact with clients and regulatory authorities.
- Ability to work well in a cross functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
- Must display in-depth understanding of FDA trends, FDA and EU regulation. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.
- Must display the ability to lead teams and handle project management activities with supervision.
- Must be able to travel domestically and/or internationally up to 25% of the time.
- Must demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities/assignments.
- Must demonstrate effective communication skills and technical writing ability.
- Ability to work in fast paced environment, with multiple external clients.
- Ability to work independently with minimal supervision, in addition to group/team setting.
- Ability to complete tasks with accuracy and efficiency.
- Portrays appropriate levels of integrity and professionalism.
- Ability to communicate effectively with management and staff.
- Excellent written and verbal skills.
Qualified candidate must have at least a bachelor's degree with a minimum of 5 years of progressive, challenging QA/QC experience in pharmaceutical, medical device or biotech industries with an aseptic filling environment preferred. Certification as a CQA Auditor preferred or the ability/experience to study and obtain certification in 12 months. Must have at least 2 years of experience in pharmaceutical quality audits including both external and internal auditing. At least one year of FDA system-based inspection is required. In-depth knowledge of cGMP regulations is required. In-depth knowledge of aseptic processing preferred. This level of knowledge is normally acquired through completion of a bachelor's degree in the sciences and applicable relevant experience.
GRAM supports Equal Opportunity Employment