Director of Quality Control, Pharma

Biogen•Research Triangle Park, NC

11d

About The Position

About This Role: As the Director of Quality Control , you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this pivotal role, you will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in our Parenteral Filling, Antisense Oligonucleotide, and Oral Solid Dose (OSD) operations at RTP Pharma. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments & equipment , testing procedures. Your contributions to overall site strategy, global milestone projects, and ensuring adherence to all regulatory requirements will all be in support of our clinical and commercial supply chain. What You’ll Do: Lead the Pharma Site QC Operations organization – Management of effective and efficient cGMP compliant QC laboratory operations and effective partnership within Global Quality.  Plan, implement and direct activities of QC Operations Lab supervisors and managers in core functions that include all types of sampling and testing activities; provide technical support as well as facilitation of major investigations; all in support of business and manufacturing schedules. Be accountable for QC personnel staffing, their training, development, and performance consistent with requirements of GMP compliant Quality Control operation. Ensure adherence to safety regulations and requirements. As an extended member of the RTP Pharma Site Leadership team, contribut e to organizational focus and strategic planning. Establish and maintain fully effective laboratory systems to ensure integrity of all laboratory results. Ensure tracking and trending are completed and evaluated for QC functions. Responsible for audits and site management review.  Ensure tasks are completed to meet business initiatives within a suitable timeframe . Collaborate with various teams including Manufacturing, MFG Sciences, Technical Development, Quality Assurance, Regulatory, and Global Quality to facilitate cross-functional success. Develop and manage QC budget plans, ensuring financial discipline and alignment with company near and long-term growth strategies Manage key site and global milestone projects, maintaining adherence to all regulatory licenses and regulations. Provide technical support, facilitate major investigations, and ensure QC laboratory operations support business and manufacturing schedules. Drive compliance and quality by supporting analytical method and process validation, instrument qualifications, and adherence to safety regulations. Who You Are: You are a leader who thrives in a dynamic environment and possesses a strong background in Quality/Quality Control within the biotechnology manufacturing sector. You have a proven track record of leadership at the site level . Your expertise extends to managing GMP-compliant QC operations and you are adept at strategizing to meet business needs. You are committed to developing your team while fostering a culture of safety and excellence . You understand the critical nature of your role and approach each challenge with a problem-solving mindset, driving continuous improvement while ensuring the highest quality standards are upheld.

Requirements

Bachelor’s degree (B.S.) in Microbiology, Chemistry, Biochemistry, Biological Sciences, or a related field
A minimum of 12 years of relevant experience, including direct people leadership of 6 + headcount , with a history of advancement and exposure at site leadership and organizational levels
Strong understanding of GMP compliant Quality Control operations within a biotechnology setting
Experience with creat ing a robust environmental monitoring program
Experience with parenteral filling (sterile filling for vials, cartridges, and syringes ) and /or Antisense Oligonucleotides
Demonstrated ability in developing and managing budgets and QC infrastructure
Proven track record of successful cross-functional collaboration and project management
Expertise in laboratory systems, analytical methods, and compliance with regulatory requirements
Proficiency in data analysis, trending, and reporting within a QC framework

Nice To Haves

Experience with strategic planning and execution in a global quality context

Responsibilities

Lead the Pharma Site QC Operations organization – Management of effective and efficient cGMP compliant QC laboratory operations and effective partnership within Global Quality.
Plan, implement and direct activities of QC Operations Lab supervisors and managers in core functions that include all types of sampling and testing activities; provide technical support as well as facilitation of major investigations; all in support of business and manufacturing schedules.
Be accountable for QC personnel staffing, their training, development, and performance consistent with requirements of GMP compliant Quality Control operation. Ensure adherence to safety regulations and requirements.
As an extended member of the RTP Pharma Site Leadership team, contribut e to organizational focus and strategic planning.
Establish and maintain fully effective laboratory systems to ensure integrity of all laboratory results. Ensure tracking and trending are completed and evaluated for QC functions. Responsible for audits and site management review.
Ensure tasks are completed to meet business initiatives within a suitable timeframe .
Collaborate with various teams including Manufacturing, MFG Sciences, Technical Development, Quality Assurance, Regulatory, and Global Quality to facilitate cross-functional success.
Develop and manage QC budget plans, ensuring financial discipline and alignment with company near and long-term growth strategies
Manage key site and global milestone projects, maintaining adherence to all regulatory licenses and regulations.
Provide technical support, facilitate major investigations, and ensure QC laboratory operations support business and manufacturing schedules.
Drive compliance and quality by supporting analytical method and process validation, instrument qualifications, and adherence to safety regulations.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation