Manager, Document Control and Training (QA-1038)
AN2 Therapeutics, Inc. (AN2) is a biopharmaceutical company focused on developing novel anti-infective medicines for patients with rare, chronic infectious diseases – including global and neglected tropical diseases – that have significant unmet medical needs for new therapies. Founded by a team of experienced industry leaders in infectious diseases drug research and development, we strive to provide patients with treatments that will restore their health and enable them to live productive lives. AN2 is a mission-driven company with a passion for improving global public health and a vision to accelerate development of novel medicines to treat serious infectious diseases and save lives worldwide. We believe our company thrives when all employees share this mission.
AN2 is seeking a Manager, Document Control and Training to be responsible for supporting the Quality Management System and continuous improvement exercises, initiatives and processes to ensure compliance with quality objectives, regulatory requirements and GXPs across the organization. This position will report to the Vice President, Quality Assurance.
- Manage the change processes to ensure compliance with current GXPs, including document change requests, label changes and external change controls.
- Work with primary originators of documents to ensure that GXP related controlled documents (e.g., Policies, SOPs, forms, specifications, etc.) are authored, reviewed, edited, formatted and approved in a timely manner.
- Author Quality and GXP related controlled documents as assigned, and work with functional departments to ensure accuracy, feasibility and completeness.
- Manage the periodic review of controlled documents.
- Administer the GXP training program. Ensure complete and accurate training records for personnel involved in GXP activities.
- Assist managers and others in creating training curricula, materials, documentation and deliver training on document control and/or training procedures and practices as required.
- Serve as training representative for Quality with other departments and as a project resource for training projects as required.
- May provide oversight and training for AN2 staff and temporary help for short-term projects.
- Support upkeep and maintenance of Quality Management subsystems including CAPA, deviation, OOS, Material Review and oversee completion of actions, closure and verification of effectiveness checks.
- Provide support and coordination of the Batch Record Review and Disposition process including providing notifications, tracking process of reviews and archiving completed documents.
- Maintain tracking logs as assigned or requested.
Metrics and Trending
- Develop and support metrics gathering, monitoring and reporting for Quality Management System including Change Control, Clinical Complaints, CAPA, Deviation, OOS, Supplier Quality, TAT, training, etc.
Audits and Inspections
- Support mock recalls of drug substance and drug product batches.
- Support audit process including internal and mock audits; regulatory inspections.
- Lead continuous improvement initiatives.
Qualifications and Experience:
- BA/BS in a scientific discipline or equivalent education/experience
- Minimum, five years’ previous experience in a Quality-related role in pharmaceutical, biotechnology or other regulated industry
- Minimum, five years’ previous Quality Management System experience
- Strong knowledge of GXPs in a regulated industry
- Strong knowledge of regulatory requirements for the pharmaceutical or biotechnology industries (21CFR Parts 11, 210, 211; ICH Q7, Q9 and Q10)
- Working current knowledge of Quality Assurance methodologies
- Self-starter requiring limited task supervision
- Able to collaborate, influence and work effectively across multiple departments
- Able to make decisions based on company and/or quality policies and procedures
- Ability to read, interpret and apply quality standards, SOP’s, specifications and work instructions
- Strong data gathering, metrics development, and report generation skills
- Strong analytical and problem-solving skills
- Strong organization and detail skills
- Strong verbal and written communication skills
- Strong interpersonal skills
- Excellent MS Office skills
- Strong Quality Management System knowledge and skills
- Proficiency in QMS or DMS software’s preferred
- Proficient in Adobe Acrobat Pro
- Proficient in Visio
By joining our small, highly dedicated and motivated team, you will experience a culture that is inclusive, supportive, and humble, yet challenging. We set our egos aside to collaborate for the benefit of the team, and most importantly, the patients in need of new therapeutic options. AN2 is a company with a passion for improving global public health. We approach our business using a double bottom line strategy – with the intention of a fiscal and social return - this is reflected in our Core Values and is the foundation of our company’s culture. We employ the industry’s best to create a corporate culture that is fun, humble, respectful, and fulfilling, and where employees feel that they are making a difference and feel inspired to bring their passion to work.
We are an equal opportunity employer that values diversity, equity, and inclusion. We consider all qualified applicants regardless of race, sex, gender identity or expression, sexual orientation, age, religion, national origin, marital status, veteran status, or ability status. We will ensure that individuals who are differently abled are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment as provided to other applicants or employees. Please contact us to request accommodation.
Our open positions are managed through our Human Resources department. Unsolicited resumes from recruiting agencies, in advance of a specified agreement, will not be accepted. Resumes sent directly to our employees or our consultants from recruiting organizations will also not be accepted as referrals and do not obligate us to pay fees.
Please send your resume to careers@AN2Therapeutics.com and include the job title and number in the subject.