Current Opportunities

Director QA Compliance - Northern CA

The Compliance Head is responsible for the overall compliance of the site’s systems of handling, manufacturing and distribution of biopharmaceutical drug substance.

Makes sure that all aspects of the handling, manufacturing and distribution of biopharmaceutical products at the site comply with relevant cGMP regulatory and legislative requirements. Ensure that local quality systems and standard operating procedures are in place and that compliance with cGMP is maintained through training and audit. Manage the implementation of Corporate Policies to ensure quality processes are maintained and current. Manage critical complaints, recalls, counterfeits and product tampering. Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters are provided to the whole site. Ensure that coordinated contact is maintained with the regulatory authorities and the local partners (suppliers, third parties, licensees, distributors). Directs and oversees investigations and studies. Ensure readiness for and plan, manage and lead Health Authority and partner inspections.

Related experience should be in GMP-regulated industries. Must have a working knowledge of FDA and international regulatory requirements as well as industry quality management tools, standard, and quality systems. Must have an understanding of pharmaceutical industry trends and practices. Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.

Head of Global Quality Assurance - Munich, Germany

QA Head will be responsible for Global Quality Management including all manufacturing sites, Third Party Suppliers and Development activities: Ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements as well as corporate Quality Policies. Ensure that compliance and quality risks are understood and are always integral part of business decisions. Liaises with Development and Technical Operations to prospectively plan QA support for project milestones. Initiate all quality improvement and CAPA activities to assure timely successful completion. Support and supervise cGMP upgrade projects and ensure compliance with industry standards. Ensure site readiness for regulatory inspections. Ensure that sites QA are meeting global standards and principles with respect to organization, personnel qualification training, procedures, processes, performance and productivity. Evaluate performance reports of sites QA, initiate corrective actions where necessary, and perform follow-up on resulting measures and provides transparency. Support/supervise communications to regulatory authorities within areas of responsibility.

Education: Graduate in Biochemistry, Chemistry, Pharmacy, Microbiology or another related science. Languages: English fluent in speaking and writing. Experience: Biotech QA Expert, 10+ years experience within the pharmaceutical industry, e.g. in Pharmaceutical Production and QA Operation. Profound GMP & GCP experience. Strong Leadership skills and experience in Matrix organization.

Senior Director of Quality - Boston area

The Senior Director is responsible for the planning and implementation of all quality activities (Quality Assurance and Quality Control) for the company. Oversees all quality activities as they relate to both development and commercial products. Provides leadership to entire Quality function as well as oversight of contract facilities. Develops and implements strategies, policies and programs in support of quality functions.

Establishing and modifying, as necessary, vision for overall Quality requirements by the Company, partners, contractors and suppliers.Developing and maintaining quality systems for the Company in compliance with all regulatory agency requirements for the markets served, to oversee: Production Systems, Material Systems, Laboratory Control Systems, Packaging and Labeling Systems, Facilities and Equipment Systems. Developing and continually improving the strategy for policies and procedures, ensuring compliance with regulatory agency and partner requirements. Recruit and train staff to comply with Company standards as well as reinforcing training and motivating individuals. Provide effective leadership in attracting, retaining and developing staff. Manage internal and external resources for the quality oversight, testing and disposition of API and drug product. Manage domestic and international facilities which are owned or contracted by Company. Mange GCP, GLP and GMP activities related to clinical and commercial products. Support Due Diligence and CMC Documentation for submission to worldwide regulatory agencies, with partner input. Works cross-functionally and representative on cross-functional teams in support of the business.

Education: A BS or MS in a scientific discipline or equivalent. Minimum of 15 years of quality experience in a biotechnology or pharmaceutical environment.

Director Quality Management & Compliance - Pennsylvania

Responsibilities include running all aspects of Quality/Compliance for a full service, e-Clinical services firm: Develops and enhances quality processes to promote, facilitate and ensure compliance with all regulatory and company standards by: Evaluating, interpreting and applying FDA regulations and policies. Managing the writing, revising, reviewing and approving of all Standard Operating Procedures. Serving as site contact for communication with the FDA and other regulatory agencies. Providing training and guidance to staff regarding compliance and interpretation of regulations. Auditing systems and staff competency for overall facility compliance to FDA requirements.

Designs, develops, implements, leads and manages all quality assurance programs by: Managing site audits as requested by clients and/or regulatory agencies. Overseeing and enforcing quality initiatives and companywide compliance with regulatory requirements. Participating in the development and maintenance of all quality systems and process improvements. Leading and investigating quality issues and implementing corrective actions; identifying departmental strengths and weaknesses. Developing and implementing proper document management and change control processes. Providing regulatory guidance to management team.

Bachelor’s degree in the life sciences or related field; advanced degree is preferred. 7+ years current experience in a Regulatory or Quality Assurance role within the pharmaceutical industry. 5+ years management experience in clinical development within the pharmaceutical industry. 5+ years experience in creating and maintaining SOPs. Expertise in developing and maintaining quality management systems related to software development in a regulatory environment. Expertise in Quality Assurance auditing and regulatory affairs. Must be familiar with US and EU regulations and guidance.

Supplier Quality Manager - Massachusetts

The Manager will lead a group which oversees the quality aspects of contract manufacturing operations, global logistics, supply chain operations and supplier quality functions. Responsibilities include QA oversight and compliance of: quality systems; certain program oversight; Contract Manufacturing Organizations’ (CMO); external warehouses; distributors; raw material suppliers. Responsible for bulk and finished drug product manufacturing/ testing oversight and final lot disposition. Groups also support external partners (marketing partners, logistic partners).

The QA Manager is responsible for implementation, management and oversight; group’s compliance to GMP and GDP, according to the relevant regional regulations. The manager is accountable for defining and achieving the functional area goals and objectives as they relate to departmental and corporate goals. Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, DNA leadership capabilities, performance management and department budget.

Bachelor’s degree in chemistry, biology or a related discipline. Minimum of 7 years experience working in cGMP environment with a minimum of 4 years Quality Assurance experience supporting the manufacture of drugs, biologics, or devices. Quality experience in parenteral biotech manufacturing (aseptic or sterile processing). Management experience. Demonstrated leadership and management skills. Thorough understanding of quality systems and cGMPs. Must be able to prioritize and multitask in a stressful environment.

Senior GMP QA Specialist -Massachusetts

In this newly created role, the Senior QA Specialist will perform a wide array of Quality Assurance activities focusing on compliance as defined by the Corporate Quality procedures in support of early phase active pharmaceutical ingredient and drug product manufacturing. Will assist in the development, implementation and management of Quality Assurance programs and initiatives. Reviews and approves Good Manufacturing (GMP) documentation and provides Quality guidance in accordance with applicable regulatory requirements. Candidate should have experience working with Contract Manufacturing Organizations (CMOs) and have experience with dispositioning product in support of multinational clinical trials.

Senior GCP QA Auditor - Massachusetts

The Senior QA Auditor takes part in the development, implementation and management of Research & Development Quality Assurance programs and initiatives. Conducts internal and external audits to assess compliance with regulations and company policies and procedures. Serves as Quality / GCP resource for clinical teams.

Collaborates with Clinical Research / Clinical Operations personnel to ensure that clinical trials comply with SOPs, FDA regulations, and ICH/GCP guidelines. Provides expert GCP compliance and general QA support; acts as liaison between product development teams and QA. Plans, coordinates and conducts internal and external (domestic and international) GCP-related audits: Investigator Site Audits, System/Process Audits, Vendor Audits (CROs, Labs), Data Audits, Trial Master File (TMF) Audits, Document Audits (protocol, ICF, IB).

Bachelor’s degree in a scientific discipline. 5 years in a pharmaceutical quality assurance / compliance role. At least 3 years experience in an GCP auditing role, with one year as a lead auditor.

Director QA - Midwest location

The Director of QA must have knowledge and experience to provide strong leadership in support of cGMP manufacturing of vaccines, including thorough knowledge of and experience with: Document control, batch releases, deviation systems, CAPA, change control, product inquires/complaints, process validation and qualification requirements.

Concurrently lead daily operational initiatives while developing strategic plans for future department and Quality division growth. - Manage and mentor Quality management staff to emphasize positional responsibility, personnel development and succession planning throughout the unit. Provide direct oversight of inspections and follow-up activities for the US FDA (CBER) and other regulatory agencies. Participate in interdepartmental/site leadership and operational excellence initiatives. Interact with other functional areas to define project requirements and objective.

Bachelors in Chemistry, Biochemistry, Biology, Microbiology or related science discipline. 10 or more years of cGMP Quality experience (QA/QC/Validation) with 5 years in roles of increasing management responsibility in a biopharmaceutical manufacturing environment.

Director GCP Compliance - Boston area

The Compliance Director will ensure that there is effective implementation and maintenance of systems and procedures required for compliance with Good Clinical Practices (GCP) regulations and ICH requirements. This position will also ensure that there is an effective implementation of applicable state, federal and regional requirements. The Compliance Director must ensure that the company policies that govern the conduct of clinical studies for drugs/biologics, medical devices and diagnostics are being followed and meet applicable requirements. The Compliance Director will execute organizational policies and procedures and participate in their change and development as needed.

The Compliance Director will manage their assigned corporate GCP compliance audit activities including, but not limited to, vendors, internal and investigation sites supporting clinical studies.

The Compliance Director will act as Corporate Quality Compliance representative providing leadership to Clinical Teams and Biomedical Operations.

This position requires BA/BS Degree within Science, Health Care or equivalent and 12+ years of GCP compliance related quality experience. Strong verbal and written communication skills are required. A Compliance Director must have the ability to work effectively in a matrix, team setting. Auditing investigational sites ex-US and having global GCP experience is highly desired.

QA Team Leader - Massachusetts

Responsible to supervise, lead, plan, organize, guide, and monitor employee accomplishments within the QA group to assure efficient and effective contribution to organization objectives. Focus is on a quality system approach with the manufacturing department and to work closely with other departments/groups to maintain a high level of quality in execution and documentation of drug products manufactured at the site. Responsible for managing assigned staff to ensure objectives and deliverables are understood and met.

Manage the batch review program to ensure timely release of drug product. Facilitate EU batch record review and Qualified Person release of products manufactured on site. Maintain and manage the internal and external audit program for US activities. May lead and direct audits of GMP materials and service providers.

5 or more years of experience in relevant quality systems, technology and/or supervision in an FDA-regulated biotechnology or pharmaceutical environment. GMP and GLP auditing experience. Strong communication, supervisory, organizational, and interpersonal skills. Detailed familiarity with cGMP requirements and current industry practices