At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

The QA Associate Director possesses and applies knowledge, expertise and global experience in the principles and applications of GxP, CLIA and other applicable regulations.

• Ensures that the Boston site is compliant to all applicable requirements and health authority regulations, including FDA, MHRA, EMA, PMDA and other national regulators. 
• Negotiates Quality agreements with each Sponsor (client) and ensures that these agreements are acceptable to, and consistent with the BioAgilytix Quality System.
• Ensures work performed at the Boston site is compliant with all applicable, approved Quality Agreements.
• Leads, manages, develops and mentors Quality Assurance (QA) team members
• Acts as department lead in the absence of the Senior Vice President, Quality Assurance, Director, Quality Assurance, or Senior Director, Quality Assurance
• Responsible for coaching and counseling QA team members; negotiates with others to remove roadblocks and resolve disputes; delegates responsibilities to qualified QA staff.
• Makes hiring decisions for site QA team.  Partners with colleagues in HR and other functions to ensure that team recruiting, selection, orientation, and training is effective; provides opportunities for growth for team members.
• Designs and continually improves the quality systems, procedures and processes used at the Boston site to ensure efficient, compliant operations.
• Manages site QA budget and approves headcount.
• Oversees the performance of all Quality Assurance staff at the site and ensures that key performance indicators are defined, measured and controlled.
• Provides oversight of the Quality Management System which may include managing the review of regulated data and reports, hosting vendor and regulatory agency inspections, overseeing the review of the Master Schedule, overseeing the vendor program and overseeing the computer system validations and equipment qualifications
• Leads (hosts) the conduct of sponsor audits, leads and performs QA audits, inspections and monitoring procedures against standard operating procedures, methods, protocols, guidance for industry documents, and/or regulations, as applicable.
• Oversees the writing and approval of QA SOPS and provides regulatory input for other department SOPs
• Responsible for overseeing the design, development, and implementation of records management policies, procedures, and records retention schedules for retrieving, storing, filing, and preserving official business records according to federal, state and local laws in support of the QMS
• Partners with other senior QA colleagues at the global level to manages, respond to and effectively resolve customer quality complaints, inquiries, and audit requirements relating to BioAgilytix services, with appropriate sense of urgency and business criticality.

• Other duties as needed

• Bachelor’s degree in a biological science, engineering, or related discipline
• Extensive knowledge of GxP Regulations

• Not less than 10 years’ experience working in biotech, pharmaceutical, CRO/CMO or similar organization
• Not less than 8 years working in an GxP Quality environment with not less than 3 years of management experience

• Ability to work cross functionally to define and implement solutions that are both compliant and efficient.
• Ability to set direction and make decisions in complex situations, such as the balance of regulatory compliance and operational expediency.
• Extensive experience in hosting Sponsor and government agency inspections
• Extensive experience in evaluation GxP systems and processes to ensure compliance with regulatory requirements
• Knowledge of GxP regulations to a level sufficient to support training others
• Extensive Internal and/or external GxP auditing experience
• Government agency and Sponsor inspections experience
• Ability to work in fast paced environment where multiple projects are in process and must be completed in a timely manner
• Experience in organizing and directing a cross-functional team to ensure compliance with applicable regulations for all compliance activities undertaken
• Ability to deal effectively with diverse individuals at all organizational levels
• Excellent oral and written communication skills
• Demonstrated proficiency in MS Excel and Word

• Quality certification preferred (e.g. ASQ, RQAP-GLP, RQAP-GCP, or RAC)

•        Sr. QA Manager
•        QA Manager
•        Senior QA Auditor
•        QA Auditor II
•        QA Auditor I

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

• Primarily office
• Work requires occasional travel 

• Ability to work in an upright and/or stationary position for up to eight (8) hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
• Occasional mobility needed
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moving) objects, including files and laptop computer, with a maximum lift of 20 pounds
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Ability to perform under stress and multi-task
• Regular and consistent attendance

• This is a full-time position
• Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of any employment Visa at this time.

BENEFITS AND OTHER PERKS

Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (10 scheduled; 3 floating), 401k with Employer Match, Employee Referral Program

COMMITMENT TO EQUAL OPPORTUNITY

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.