VP, QUALITY ASSURANCE & QUALITY CONTROL - Northeast
The Company:
Our client is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. The Company has five product candidates in clinical development and several others in preclinical development.
Basic Function:
Responsible developing strategies to implement Quality Systems that assure all manufacturing and related activities for small molecule and biologic products in clinical development and in commercial market are in compliance with all US and international regulatory requirements. Manage all activities related to QA/QC in-process and incoming inspections, batch releases, internal and external auditing. Ensures compliance with current Good Manufacturing Practices (CGMPs), government regulations, industry standards and company procedures (SOPs). Maintains efficient and effective QA/QC functions to assure timely release of product. Manages and supports the ongoing development of quality systems. Internal projects include: ongoing program development on methylnaltrexone, PSMA, PRO 140, GMK and PRO 542.
Responsibilities:
� Develop and execute plans to provide QA oversight of in-house and outsourced manufacturing activities to meet project goals.
� Prepare CMC documentation to meet project goals.
� Serve as compliance expert to direct Company�s programs in biologics and small molecules. Functions as Company�s principal quality expert on small molecules.
� Manage in-process and incoming inspections and oversee the investigation and resolution of quality related problems, as necessary.
� Establish and approve in-process and finished goods disposition; coordinate and schedule QA operations to meet product distribution requirements.
� Maintains information systems for tracking and trending finished product dispositions, including pertinent QA data for lot history.
� Review, revise and approve master batch records and standard operating procedures (SOPs) to support GMP manufacturing operations both within the Company and those contracted outside. Ensure compliance with Good Manufacturing Practices and regulations.
� Conduct internal and external audits of manufacturing operations and suppliers.
� Prepare/approve production specifications, raw materials specifications, stability protocols. Provide technical input into development of QC methods and assay validation protocols.
� Review completed batch records to assure timely release of clinical supplies.
� Review and approve Validation Master Plan for manufacturing facility and equipment. Provide Quality support to all validation programs. Review and approve validation protocols and execution reports.
� Responsible for pre-approved inspection programs.
� Initiate follow-up activities on any reported CGMP violation and/or deficiencies to assure a timely resolution and enforce corrective actions.
� Work with other managers to establish quality goals and procedures.
� Develop and deliver training programs for Quality personnel; assist in regulatory inspection activities, as necessary.
Qualifications:
� 10+years Quality management experience in pharmaceutical or biotechnology industry.
� Experience in bringing a drug/biologic to market including NDA/BLA filing and pre-approval inspection.
� QA operations with strength in small molecules.
� Working knowledge of current Good Manufacturing Practices (CGMPs), quality systems, systems to assure compliance with international regulatory requirements and Chemistry, Manufacturing and Controls (CMC).
� Must possess sound understanding of pharmaceutical quality principles.
� Requires a strong CGMP compliance background and good regulatory understanding.
� Equipment/facility and process validation experience.
� Experience in strategic planning, budget management and personnel development is required.
� Background in documentation review and control is a plus.
Personal Characteristics:
� Resilient, able to work well under pressure and meet deadlines.
� Superior intellect, with an ability to intellectually challenge and be challenged by others.
� Effective interpersonal skills exemplified by an articulate, persuasive and enthusiastic manner.
� Credibility and commitment combined with a genuine empathetic and collaborative style i.e. a team builder.
� Decisive with a bias towards action in both internal and external situations balanced with unquestionable ethics, values and professional integrity.
� Candidate should have strong interpersonal, organizational and communication skills and attention to detail is essential.
� Must have a demonstrated ability to work with various levels of management, ability to work in a multidisciplinary team environment.
Education:
Requires a Masters Degree or Ph.D. in Biology, Chemistry of life-science field.
Opportunity:
The successful candidate will be a key addition to the management team providing leadership in many aspects of the business. Given the achievement of certain agreed upon milestones, this individual will be strongly considered for succession planning to more senior level executive positions.
Travel: 20 to 30% travel, mostly domestic with some international.
