POSITION SUMMARY: 

The Sr Director of Quality Compliance is responsible for developing, implementing and improving processes and activities of the Quality Compliance team that ensure the safety and effectiveness of all products produced by MassBiologics for human use, the inspection readiness and the adaptability of the Quality Systems to future projects and external clients. The Sr Director is primarily responsible for the proper implementation of quality processes in accordance with current standards regulations (EUR, US, and other international markets) and external clients quality systems, ensuring their performance across all MBL entities (Mattapan, Worcester and SouthCoast campuses) to achieve the best-in-class quality management system.

Ensures, through the definition and the implementation of processes and an active collaboration with operational teams and digital teams and external Quality partners, the successful deployment of Quality tools and digital solutions, supporting the transformation of the Sites.

The Sr Director of Quality Compliance is the primary representative of MassBiologics with CDMO clients ensuring proper implementation and alignment on product quality matters according to the Quality Agreements. The incumbent represents the Quality Compliance team at high level meetings and designates personnel as appropriate for tactical and operational meeting.

The Sr Director collaborates and supports the implementation of different activities in the Quality Unit, including inspection and audits by clients and health agencies, other cGMP compliance systems such as: documentation training Compliance, Quality Assurance of facility equipment and systems.

This is a leadership position within the Quality Organization and MassBiologics. As part of the Extended Leadership Team (ELT) the incumbent is responsible for driving the culture of compliance and quality, demonstrate organization values and participate in strategic and tactical decisions supporting the overall effectiveness and success of the organization. In this role, the Sr Director will provide technical and scientific guidance within QA and in collaboration with other MassBiologics departments.

ESSENTIAL FUNCTIONS:

Quality Systems oversight:

• Define and assess the performance of the following quality systems in compliance with GMP standards: Deviation, CAPAs, OOS, CC and Risk management.
• Provide expertise, tools and processes to support the implementation and the continuous improvement of the key Quality Systems.
• Provide compliance and systems expertise, direction and coaching support on quality issues faced by MBL
• Design and oversight of Site GMP related plans (Quality Plan, Data Integrity plan, GMP training plan, Contamination Control plan, Site Validation Master Plan, Site Master File, etc).
• Actively contributes to the design of Quality Priorities and key performance indicators. Compiles and communicates KPIs, analyses trends and propose improvement plans. Energize & empower team to achieve collective goals

Quality Risk Management:

• Define, set and maintain the Quality Risk Management (QRM) process and associated tools in order to support the decision-making process concerning the Quality Risk Management and assessment. Management of risks related to product quality and supply continuity, regulatory and GxP compliance

Inspection readiness and audit program:

• Define and coordinate an assessment process to ensure that the site constantly remains in a compliant state, via
• Confirms MassBiologics processes conform to government and satisfies GMP regulations including those pertaining to the United States, the European Union, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and any and all cGMP quality regimes relevant to the distribution of commercial or investigational drugs produced at MassBiologics.
• Supervision by means of self-inspection/ walkthrough processes
• Management of Post Licence Commitment : Reviews and approves Quality sections of Product License Applications (BLA or IND) for submission to FDA and their equivalent in other jurisdiction and ensures that processes are performed in compliance with regulatory submission
• Management audit plan (including, self inspections, walk throughs and GEMBA walks, third parties and GMP related contractors, suppliers)
• Regulatory watch in interface with overall quality
• Set up and guarantee the appropriate level of preparation, organization and follow-up of all the regulatory inspections and clients audits (taking place on site) and coordinate the subsequent actions plan within MBL network. Ensure the Sites are always ready for inspection.
• Represent the site towards the concerned health authorities & clients during regulatory inspections and clients audits

CQ&V (Commissioning, Qualification and Validation - Quality oversight) :

• Guarantee that equipment, systems (including HVAC, clean steam, WFI, PW), computerized systems, analytical methods, cleaning procedures, packaging operations, sterilization, transportation & storage are properly qualified/validated and sustain their validated status upon changes. Ensure approval of qualification or validation protocols and reports for processes, facilities, utilities and equipment; and for computerized systems as needed
• Approves the Site Validation Master Plan.
• Quality oversight of commissioning and qualification systems.
• Oversight of maintenance and calibration programs

Supplier Quality

• Design and implement a program for suppliers quality

GxP Documentation management system

• Responsible of the documentation management system (all GMP relevant documents kept and updated as per expected standards) and Document retention policy.

Projects:

• Supports with Quality expertise all Site ongoing projects (new product introduction, technology transfer, improvement projects, among others)

Culture & Mindset:

• Promotes Health and safety culture throughout the organization, accountable for continuous development of quality mindset
• Competencies, Training and qualification system designs and approves training curricula and monitors adherence. Responsible for developing and delivering the annual GMP training program.
• Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; including appropriate training and mentoring for junior staff and development of senior staff to provide appropriate and adequate backup for primary QA leadership functions

Quality Agreements:

• By delegation of the Deputy Director, the Excecutive director is the primary representative of MassBiologics with CDMO clients ensuring proper implementation and alignment on product quality matters according to the Quality Agreements, supporting the design of the documents (QTAs). The incumbent represents the Quality Assurance team at high level meetings and designates personnel as appropriate for tactical and operational meeting

• Develops budgets and manages resources to meet departmental and organizational objectives
• Perform additional job-related duties as required.

REQUIRED QUALIFICATIONS:

• Higher level technical/scientific education and a minimum of 12 years of relevant experience
• A combination of experience and/or knowledge of and willingness to adapt to the cGMP environment of a biotech laboratory producing clinical trial materials and market licensed product is required
• Demonstration of initiative and leadership through past experience
• Relevant experience and technical knowledge in vaccines, monoclonal antibodies, viral vector products preferred.
• Demonstrated ability to interact with senior management, external clients, suppliers and regulatory officials
• Clear, concise, written and verbal communication and presentation skills
• Ability to manage risk by maintaining and applying extensive working knowledge of applicable cGMP, FDA, and EMA regulations
• Demonstrates potential for technical proficiency, scientific creativity, productive collaboration with others, and independent thought
• Strong organizational skills, demonstrated ability to prioritize projects, and to meet deadlines with minimal supervision are required
• Ability to manage performance and motivate personnel to work effectively and efficiently
• Demonstrated problem-solving skills